Sea Fare Foods, Inc. 10/24/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit. MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

 

WARNING LETTER

2012-DET-04

 

 

October 24, 2011

 

VIA UPS

 

 

Mr. Philip M. Sack, Owner

Sea Fare Foods, Inc.

2127 Brewster Street

Detroit, MI 48207

 

Dear Mr. Sack:

 

We inspected your seafood processing facility, located at 2127 Brewster St., Detroit, MI 48207 on September 12, 14, 21 and 30, 2011. We found that you have serious violations of the Fish and Fishery Products 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 hot smoked, vacuum packaged, refrigerated fish products are adulterated, 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 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). 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,

 

a.  Your firm’s HACCP plan(s) for your refrigerated, vacuumed packaged, cooked, ready-to-eat, hot smoked whitefish, sable, salmon, trout, and does not list the food safety hazard(s) of Clostridium botulinum.  

 

b.  Your firm’s HACCP plan for your refrigerated, vacuumed packaged, cooked, ready-to-eat, hot smoked herring does not list the food safety hazards of Clostridium botulinum and Scombrotoxin (Histamine) formation.

 

c.  Your firm’s HACCP plan for your “Pickled Ocean Herring in glass jars” does not list the food safety hazard of allergens, specifically milk.

 

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 exclusion of pests and the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product with sufficient frequency and accuracy to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

 

a.  Live insects were observed in the product room by our investigators on September 12 and 14, 2011; however your “Weekly Sanitation Form” for the week ending September 16, 2011, indicates “NO PESTS ARE IN THE PRODUCT AREA” for both these days.

 

b.  Our investigators observed that the same buckets filled with hot water, which were used to rinse the white cloths used to wipe the rims of the uncapped glass gars of ready-to eat creamed herring, where also used to clean the employees hands.

 

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

 

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 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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 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: Steven B. Barber: Director, Compliance Branch, 300 River Place,  Suite 5900, Detroit, MI 48207.   If you have questions regarding any issues in this letter, please contact Mr. Barber at 313-393-8110.

 

Sincerely,

/S/

Glenn T. Bass

District Director

Detroit District Office