Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7194
FAX: (612) 334-4142
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 18
Stanley F. Jide, CEO
Charles N. Chiefredo, COO
Bayo O. Mafe, CFO
BCS African Wholesale Food Supply Inc.
7340 Brooklyn Boulevard
Brooklyn Park, Minnesota 55443
Dear Messrs. Jide, Chiefredo, and Mafe:
We inspected your wholesale foods facility located at 7340 Brooklyn Boulevard, Brooklyn Park, Minnesota, on February 2 to March 3, 2010. The Minnesota Department of Agriculture inspected your same facility under contract with us on March 31, 2010, and on April 7, 2010. 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 (GMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 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 uneviscerated smoked/dried fish (including Pike, Jack Cavalli, Bony fish and Kangbe fish), smoked fish and seafood (including smoked Herring Bloaters, smoked Barracuda, smoked Catfish, smoked Pike), and other various frozen and fresh fish (including snails, Red Snapper and Titus sardines) are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
In addition, our investigators documented serious deviations from the GMPs relating to palm. oil, rice, beans, and other packaged food products, that cause the products being held and/or repackaged in your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance, and the Current Good Manufacturing Practice regulation for foods through links on FDA's home page at www.fda.gov.
Your significant violations were as follows:
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. Our investigator documented that your firm receives uneviscerated smoked dried fishery products that exceed 5 inches. FDA has determined that Clostridium botulinum is reasonably likely to grow and produce toxin in fishery products during the drying process when fish are uneviscerated; and that there is no process that would adequately control the hazard when fish are larger than 5 inches and are uneviscerated. Accordingly, your uneviscerated fishery products that exceed 5 inches in length are adulterated under section 402(a)(4) of the Act. If you had conducted a hazard analysis for these products, you would have rejected them.
2. You must have product specifications for your "bony fish," crayfish and tilapia that you import from Nigeria and China specifically to address the hazards of Clostridium botulinum growth and toxin formation and pathogen growth. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i).
3. You must implement an affirmative step to ensure that the "bony fish," crayfish and tilapia that you import from Nigeria and China were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii).
4. 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 and 21 CFR 123.11(b). However, your firm did not monitor the eight areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR as evidenced by:
A. The condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)] -- The metal saw used to portion fish was observed to contain food debris on 2/17/10 and 3/31/10.
B. The maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)] -- The hand sink in the processing room was clogged and slow draining on 2/24-25/10, and had no hand towels available on 3/31/ 10.
C. General maintenance of building, fixtures, and other physical facilities in sanitary condition and in repair sufficient to prevent food from becoming adulterated [21 CFR 110.35 (a)]. Several gaskets on freezers were missing or damaged, and there was debris along the walls on the south and east sides of the warehouse on 3/31/10.
D. The exclusion of pests from the food plant [21 CFR 111(b)(8)] -- On 3/31/10 there was a large crack between the floor and wall on the east wall of the facility and several dead insects and rodent droppings were behind the pallets.
E. Sanitation of food contact surfaces [21 CFR 110.36(d)]. On 3/31/10 the palm oil drums used in the rebottling of palm oil had food buildup inside and outside the drums.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 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 verification records, 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 processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current 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 the Food and Drug Administration, Attention: Rebecca L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.