Inspections, Compliance, Enforcement, and Criminal Investigations
BEK Catering LLC dba Floppers Food 1/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
January 6, 2012
WARNING LETTER NO. 2012-NOL-10
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Kyle D. Huxen, President
BEK Catering LLC dba Floppers Food
13045 County Road
Loxley, Alabama 36551
Dear Mr. Huxen:
The U.S. Food & Drug Administration (FDA) inspected your seafood processing facility, located at 13045 County Road, Loxley, Alabama, on September 28-29, 2011. We found 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 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 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 United States Code (USC) § 342(a)(4), 21 USC 324(a)(4)]. Accordingly, your seafood products are adulterated, as 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 on FDA's Internet 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 you produce to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have HACCP plans for your seafood products – Mama’s Gumbo; Shrimp Locksley; and, Crawfish Locksley – to control the food safety hazards of: allergens; and, pathogen growth and toxin formation from time/temperature abuse.
2. You must maintain sanitation control records which, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm does not maintain sanitation monitoring records for the: a) condition and cleanliness of food contact surfaces; b) prevention of cross-contamination from insanitary objects; c) maintenance of hand washing, hand sanitizing, and toilet facilities; d) protection of food, food packaging material, and food contact surfaces from adulteration; e) proper labeling, storage, and use of toxic chemicals; f) control of employee health conditions; and, g) exclusion of pests.
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 fifteen (15) working days from receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations. You should include in your response documentation such as HACCP and verification records, or other useful information, to assist us in evaluating your corrections. 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.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Ms. Asente at (504) 832-1290 extension 1104.
Patricia K. Schafer
New Orleans District
Enclosure: FORM FDA 483, dated September 29, 2011