Inspections, Compliance, Enforcement, and Criminal Investigations
Chris' Seafood 7/23/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
July 23, 2009
WARNING LETTER NO. 2009-NOL-12
DELIVERY SIGNATURE REQUESTED
Judy D. Zirlott, Owner
14921 Bellingrath Road
Coden, Alabama 36523-3343
Dear Mrs. Zirlott:
We inspected your seafood processing facility, located at 14921 Bellingrath Road, Coden, Alabama, on March 11, 12, 13, and 16, 2009. 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 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 which 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 Food, Drug and Cosmetic Act (the Act) and 21 United States Code (USC) 342(a)(4). Accordingly, your crabmeat and shrimp products are adulterated, because 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 Internet home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct or have conducted a hazard analysis for each kind of fish and fishery products which 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 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 a HACCP plan for cooked ready-to-eat crabmeat to control the food safety hazard of pathogen growth and you do not have a HACCP plan for shrimp to control the food safety hazard of additives, specifically sulfites.
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 did not maintain sanitation monitoring records for condition and cleanliness of food contact surfaces; prevention of cross-contamination; maintenance of hand washing, hand sanitizing, and toilet facilities; protection from adulterants; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests required for the processing of ready-to-eat crabmeat on March 11, 2009, and lQF frozen shrimp thawed and de-headed from March 11-16, 2009.
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 in violation of Section 402(a)(4) of the Act [21 USC 342(a)(4)] and the seafood HAACP regulation. We may take further action to enjoin your firm from operating in violation of Section 415 of the Act [21 USC 350d] and 21 CFR 1, Subpart H.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information which would assist us in evaluating your corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
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), and is registered in accordance with the Food Facility Registration regulation (21 CFR 1, Subpart H). You 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: Kari L. Batey, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
H Tyler Thornburg,
New Orleans District
Enclosure: Form FDA 483