FDA issued Warning Letters to three seafood processors with issues related to development and implementation of HACCP plans.
El Rey USA Meats & Seafood Inc., Chicago, IL, an importer of Tilapia, Frozen Shrimp and Frozen Shrimp Hoso did not have or have not implemented written verification procedures and an affirmative step for ensuring that fish and fishery products imported are processed in compliance with the US Seafood HACCP regulation. All fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.
Rio Verde Food Service Inc. Des Moines, IA , a processor of fish or fishery products, specifically live oysters, for failure to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements. The HACCP plan for Live Oysters lists a critical limit in the plan for receiving and storage of the refrigerated product that does not control the pathogen hazard. Processors of seafood intended to be eaten raw must ensure the temperature of the product was held at or below an ambient temperature of 40°F (4.4°C) throughout transit. There were issues with the corrective action procedures as well.
Feng Foods Trading Inc. New Hyde Park, NY did not have an implemented an affirmative step for ensuring that fish and fishery products imported are processed in compliance with the Seafood HACCP regulation, as required by 21CFR123.12(a)(2)(ii). Specifically, the firm did not implement an affirmative step for ensuring that the following fish and fishery products you import are processed in compliance with the Seafood HACCP regulation:
Granular Ark, Yellow Croaker, and Razor Clam from (b)(4) located in (b)(4)
Frozen Anchovy from (b)(4) located in (b)(4)
Fish Roe Prawn Paste from (b)(4) located (b)(4)
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-rey-usa-meats-seafood-inc-722157-02192026
El Rey USA Meats & Seafood Inc.
MARCS-CMS 722157 — February 19, 2026
Recipient:
Mr. Daniel Leon Sr.
CEO
El Rey USA Meats & Seafood Inc.
2101 W. 74th St
Chicago, IL 60636-3652
United States
Issuing Office:
Office of Inspections and Investigations
United States
February 19, 2026
WARNING LETTER
Re: CMS# 722157
Dear Mr. Daniel Leon Sr.,
We inspected your seafood importer establishment, located at 2101 W. 74th St. Chicago, IL., 60636-3652 on January 5, 2026, through January 9, 2026. We conducted a previous inspection on November 15, 2022, through November 17, 2022, which resulted in your firm receiving a letter from FDA dated January 23, 2023, that explained your firm’s non-compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations Part 123 (21 CFR Part 123). This current follow-up inspection found that your firm still has serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12.
As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.
Because our inspection identified serious violations for 21 CFR Part 123, your Tilapia imported from (b)(4); Frozen Shrimp imported from (b)(4) and Frozen Shrimp Hoso imported from (b)(4) are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows as noted on the FDA 483 dated 01/09/2026:
Mr. Daniel Leon Sr.
CEO
El Rey USA Meats & Seafood Inc.
2101 W. 74th St
Chicago, IL 60636-3652
United States
Issuing Office:
Office of Inspections and Investigations
United States
February 19, 2026
WARNING LETTER
Re: CMS# 722157
Dear Mr. Daniel Leon Sr.,
We inspected your seafood importer establishment, located at 2101 W. 74th St. Chicago, IL., 60636-3652 on January 5, 2026, through January 9, 2026. We conducted a previous inspection on November 15, 2022, through November 17, 2022, which resulted in your firm receiving a letter from FDA dated January 23, 2023, that explained your firm’s non-compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations Part 123 (21 CFR Part 123). This current follow-up inspection found that your firm still has serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12.
As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.
Because our inspection identified serious violations for 21 CFR Part 123, your Tilapia imported from (b)(4); Frozen Shrimp imported from (b)(4) and Frozen Shrimp Hoso imported from (b)(4) are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows as noted on the FDA 483 dated 01/09/2026:
You do not have or have not implemented written verification procedures and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.
This is a repeat observation from the previous inspection that concluded on 11/17/2022.
Specifically, your written verification procedures ("El Rey USA Meats & Seafood Preventive Controls Plan" and "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch") do not ensure that the following imported products were processed under conditions equivalent to U.S. HACCP requirements 21 CFR 123.12 (a) (2):
Shrimp from (b)(4)
Shrimp from (b)(4)
Frozen Tilapia from (b)(4)
This is a repeat observation from the previous inspection that concluded on 11/17/2022.
Specifically, your written verification procedures ("El Rey USA Meats & Seafood Preventive Controls Plan" and "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch") do not ensure that the following imported products were processed under conditions equivalent to U.S. HACCP requirements 21 CFR 123.12 (a) (2):
Shrimp from (b)(4)
Shrimp from (b)(4)
Frozen Tilapia from (b)(4)
The documents lack written specifications designed to ensure that imported shrimp and tilapia are not adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act.
Your written verification procedures do not identify which affirmation step(s) you have chosen to implement.
The document "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch" was not signed and dated at the time of the activity, as required.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
We acknowledge your response to these 483 violations, that was sent to us via email by Maria De La Luz, Operation Manager dated 01/23/2026. The response consisted of acknowledgment of the violations noted during our inspection that concluded on 01/09/2026 and a statement that you will be complying; however, this response has been deemed inadequate. On 01/30/2026, we provided Maria D. De la Luz, Operation Manager with an email explaining why this response was inadequate and as of the date of this letter, we have not received any additional information to address the inadequacies.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing your firm and the seafood products you import under "Detention Without Physical Examination," seize your product(s) and/or enjoin your firm from further violating the Act.
Please send your reply or if you have any questions regarding this letter via email to the Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, julie.scoma@fda.hhs.gov, please reference CMS #722157 on any documents or records you provide and/or within the subject line of the email.
Sincerely,
/S/
Keith Jasukaitis
Program Division Director
300 River Place, Suite 5900
Detroit, MI 48207-4291
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rio-verde-food-service-inc-719149-02272026
Rio Verde Food Service Inc.
MARCS-CMS 719149 — February 27, 2026
Recipient:
Ruben Acosta Galicia
President/Owner
Rio Verde Food Service Inc.
1800 Dixon Street, Suite H
Des Moines, IA 50316-2172
United States
ra@rioverdefoodservice.com
Your written verification procedures do not identify which affirmation step(s) you have chosen to implement.
The document "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch" was not signed and dated at the time of the activity, as required.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
We acknowledge your response to these 483 violations, that was sent to us via email by Maria De La Luz, Operation Manager dated 01/23/2026. The response consisted of acknowledgment of the violations noted during our inspection that concluded on 01/09/2026 and a statement that you will be complying; however, this response has been deemed inadequate. On 01/30/2026, we provided Maria D. De la Luz, Operation Manager with an email explaining why this response was inadequate and as of the date of this letter, we have not received any additional information to address the inadequacies.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing your firm and the seafood products you import under "Detention Without Physical Examination," seize your product(s) and/or enjoin your firm from further violating the Act.
Please send your reply or if you have any questions regarding this letter via email to the Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, julie.scoma@fda.hhs.gov, please reference CMS #722157 on any documents or records you provide and/or within the subject line of the email.
Sincerely,
/S/
Keith Jasukaitis
Program Division Director
300 River Place, Suite 5900
Detroit, MI 48207-4291
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rio-verde-food-service-inc-719149-02272026
Rio Verde Food Service Inc.
MARCS-CMS 719149 — February 27, 2026
Recipient:
Ruben Acosta Galicia
President/Owner
Rio Verde Food Service Inc.
1800 Dixon Street, Suite H
Des Moines, IA 50316-2172
United States
ra@rioverdefoodservice.com
Issuing Office:
Human Foods Program
United States
February 27, 2026
WARNING LETTER
Re: CMS #719149
Dear Mr. Galicia:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1800 Dixon Street, Suite H, Des Moines, IA 50316, from July 22, 2025, to July 25, 2025. During our inspection, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on September 19, 2025, including your revised HACCP plan for “HACCP Plan – Live Oysters”, approved August 9, 2025. Your written response did not include any supporting HACCP documentation. After reviewing your response, we continue to have concerns with your HACCP program for Live Oysters, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your Live Oysters are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.
Your significant violations of the seafood HACCP regulation are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However:
a. Your revised HACCP plan for “Live Oysters” submitted with your September 19, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not control the pathogen hazard. Processors of seafood intended to be eaten raw must ensure the temperature of the product was held at or below an ambient temperature of 40°F (4.4°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point.
b. Your revised HACCP plan for “Live Oysters submitted with your September 19, 2025, response lists a critical limit in the plan for storage of live oysters that does not control the pathogen hazard. Processors of live oysters to be eaten raw should ensure the oysters are continuously held at or below 40°F during storage.
2. Because you chose to include corrective action plans in your HACCP, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your HACCP plan for “Live Oysters” does not ensure that affected product does not enter into commerce.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include reference #719149 CMS Number on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, JD, MBA
Acting Director
Division of Conventional Foods Enforcement
Office of Compliance and Enforcement
Human Foods Program
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/feng-foods-trading-inc-720813-01162026
Feng Foods Trading Inc.
MARCS-CMS 720813 — January 16, 2026
Human Foods Program
United States
February 27, 2026
WARNING LETTER
Re: CMS #719149
Dear Mr. Galicia:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1800 Dixon Street, Suite H, Des Moines, IA 50316, from July 22, 2025, to July 25, 2025. During our inspection, the FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on September 19, 2025, including your revised HACCP plan for “HACCP Plan – Live Oysters”, approved August 9, 2025. Your written response did not include any supporting HACCP documentation. After reviewing your response, we continue to have concerns with your HACCP program for Live Oysters, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your Live Oysters are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.
Your significant violations of the seafood HACCP regulation are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However:
a. Your revised HACCP plan for “Live Oysters” submitted with your September 19, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not control the pathogen hazard. Processors of seafood intended to be eaten raw must ensure the temperature of the product was held at or below an ambient temperature of 40°F (4.4°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point.
b. Your revised HACCP plan for “Live Oysters submitted with your September 19, 2025, response lists a critical limit in the plan for storage of live oysters that does not control the pathogen hazard. Processors of live oysters to be eaten raw should ensure the oysters are continuously held at or below 40°F during storage.
2. Because you chose to include corrective action plans in your HACCP, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your HACCP plan for “Live Oysters” does not ensure that affected product does not enter into commerce.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include reference #719149 CMS Number on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, JD, MBA
Acting Director
Division of Conventional Foods Enforcement
Office of Compliance and Enforcement
Human Foods Program
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/feng-foods-trading-inc-720813-01162026
Feng Foods Trading Inc.
MARCS-CMS 720813 — January 16, 2026
Recipient:
Heng Wen Lin
President
Feng Foods Trading Inc.
35 Oak Dr.
New Hyde Park, NY 11040-3334
United States
Issuing Office:
Office of Inspections and Investigations
United States
January 16, 2026
WARNING LETTER
RE: CMS# 720813
Dear Mr. Lin:
On November 20, 2025, the Food and Drug Administration (FDA) conducted an inspection on your seafood importer establishment, Feng Foods Trading Inc. located at 35 Oak Dr., New Hyde Park, NY 11040-3334. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Yellow Croaker, Razor Clam, Frozen Anchovy, Granular Ark, and Fish Roe Prawn Paste are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1.You have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21CFR123.12(a)(2)(ii).
Specifically, your firm did not implement an affirmative step for ensuring that the following fish and fishery products you import are processed in compliance with the Seafood HACCP regulation:
Granular Ark, Yellow Croaker, and Razor Clam from (b)(4) located in (b)(4)
Frozen Anchovy from (b)(4) located in (b)(4)
Fish Roe Prawn Paste from (b)(4) located (b)(4)
Heng Wen Lin
President
Feng Foods Trading Inc.
35 Oak Dr.
New Hyde Park, NY 11040-3334
United States
Issuing Office:
Office of Inspections and Investigations
United States
January 16, 2026
WARNING LETTER
RE: CMS# 720813
Dear Mr. Lin:
On November 20, 2025, the Food and Drug Administration (FDA) conducted an inspection on your seafood importer establishment, Feng Foods Trading Inc. located at 35 Oak Dr., New Hyde Park, NY 11040-3334. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Yellow Croaker, Razor Clam, Frozen Anchovy, Granular Ark, and Fish Roe Prawn Paste are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1.You have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21CFR123.12(a)(2)(ii).
Specifically, your firm did not implement an affirmative step for ensuring that the following fish and fishery products you import are processed in compliance with the Seafood HACCP regulation:
Granular Ark, Yellow Croaker, and Razor Clam from (b)(4) located in (b)(4)
Frozen Anchovy from (b)(4) located in (b)(4)
Fish Roe Prawn Paste from (b)(4) located (b)(4)
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your reply to Food and Drug Administration, Attention: Stanley Nelson, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Stanley. Nelson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Nelson via email at Stanley.Nelson@fda.hhs.gov. Please reference CMS# 720813 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Please send your reply to Food and Drug Administration, Attention: Stanley Nelson, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Stanley. Nelson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Nelson via email at Stanley.Nelson@fda.hhs.gov. Please reference CMS# 720813 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports
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