Inspections, Compliance, Enforcement, and Criminal Investigations
Merex Inc 7/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
Case #10 200652
July 28, 2011
VIA OVERNIGHT MAIL
Mr. Jerry Nickerson
6436 Quinpool Road
Dear Mr. Nickerson:
We inspected your seafood processing facility, located at 6436 Quinpool Road, Halifax, Canada on February 21-22, 2011. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 salted fish 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 Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge receipt of your written response dated March 7, 2011 to the FDA 483 issued to your firm on February 22, 2011; however, we conclude that your response is inadequate in that you did not include any additional documentation that would enable us to verify your corrections have been completed.
We note the following serious deviations:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm does not have a HACCP plan for:
a. refrigerated, smoked herring to control the food safety hazards of histamine formation and pathogen growth and toxin formation
b. refrigerated dried salted cod, Pollock, hake, cusk, and ling fish to control the food safety hazards of undeclared allergens and pathogen growth and toxin formation, specifically Clostridum botulinum and Staphylococcus aureus.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor (I) prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; (2) protection of food, food packaging material, and food contact surfaces from adulteration with condensate and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a) The cooler next to the processing room, the raw material storage cooler and finished product cooler had rusty fans with dirt build-up that were blowing over boxed and exposed product that was stored beneath
b) The metal shelving structure appeared to be flaking rust-like flakes throughout the structures that were supporting pallets of loosely covered raw material salted fish
c) The finished product cooler had a mold-like growth and rust marks on the ceiling. This cooler designated for finished product also had partial pallets of raw material stored inside.
For additional information regarding FDA's recommended controls for the hazards and controls discussed above, please refer to Chapters 7, 13, and 14 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA's web
You should respond in writing within thirty (30) 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 a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan, any verification records, and other useful information such as repair receipts, repair invoices, photos and monitoring records, that would assist us in
evaluating your corrections. If you cannot complete all corrections before the 30 days, you should explain the reason for your delay and state when you will correct any remaining violations.
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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the facility producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts. An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation [21 CFR Part 123] is Import Alert #16-120. This alert can be found on FDA's web site at:
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, the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Product Adulteration Branch, HFS-606, Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Standra Purnell via email at email@example.com.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition