- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Ramiro J. Saborio
Recipient TitleDirector of Operations
- Baits and Sea Foods, S.A.
KM 25 Tipitapa-Masaya Highway
Parque Industrial Astro, Nave 24C
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
June 30, 2023
Reference # 661622
Dear Ramiro J. Saborio:
The United States Food and Drug Administration (FDA) conducted Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, located at KM 25 Tipitapa-Masaya Highway, Parque Industrial, Astro, Nave 24C, Tipitapa, Mangua, Nicaragua, on May 8 through 11, 2023. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. Your firm has not responded to the discussion items identified during the FFRA.
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 fresh and frozen histamine forming seafood products, including but not limited to mahi-mahi, 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 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviation is as follows:
1. The HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the food safety hazard of Clostridium botulinum growth and toxin formation, and undeclared allergens as required by 21 CFR 123.6(c)(1).
2. The HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list as required by 21 CFR 123.6(c)(2):
a. A critical control point (CCP) at the receiving of fresh whole gutted mahi mahi that is necessary to control the hazards of histamine formation during transit from the local ports to the processing plant.
b. A critical control point at the fish storage between layers of ice that is necessary to control the histamine formation hazard. The fresh whole, gutted mahi mahi fish can be stored up to 48 hours between layers of ice.
3. Your HACCP plan lists a critical limit that does not ensure control of one or more hazards. Specifically, your HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the sensory examination critical limit to control the histamine formation hazard at the receiving critical control point as required by 21 CFR 123.6(c)(3).
4. Your HACCP plan lists monitoring procedures that do not ensure compliance with the critical limit. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets as required by 21 CFR 123.6(c)(4):
a. Lists the incomplete monitoring procedure of “(b)(4)”. This procedure does not ensure compliance with the critical limit at the receiving CCP. The monitoring procedure does not list the number of fish to be analyzed for histamine.
b. Lists incomplete monitoring procedures to monitor the internal temperature of the fish at the receiving CCP. The monitoring procedure does not list the minimum number of fish to be temperature checked.
5. Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7 to ensure affected product is not entered into commerce and the cause of the deviation was corrected. Specifically, the HACCP plan for histamine forming species lists an inadequate corrective action procedure at the receiving CCP when the temperature measurement is above the critical limits.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you do not respond or if we find your response inadequate, we may take further action. 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 (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should direct your written reply to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #661622 on any submissions and on the subject line of any emails to us.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied Nutrition