Inspections, Compliance, Enforcement, and Criminal Investigations
Williams Seafood of Arapahoe Inc. 01-Nov-06
Department of Health and Human Services
Public Health Service
Atlanta District Office
November 1, 2006
VIA FEDERAL EXPRESS
Sherre L. Midyette, President
Williams Seafood of Arapahoe Inc.
2383 Don Lee Road
Arapahoe, NC 28510-9534
Dear Mrs. Midyette:
We inspected your seafood processing facility located at 2383 Don Lee Road, Arapahoe, North Carolina on September 20-22, 2006. 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 canned pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 implement the monitoring procedures that you have listed in your HACCP plan, as required by 21 C.F.R. 123.6(b). However, your firm did not follow the monitoring procedures of can-seam tear down evaluation at the packing and seaming critical control point (CCP) to control the food safety hazard of pathogen growth listed in your HACCP plan for canned pasteurized crab meat. [Redacted] lots of product were processed between 8/9/06 and 9/19/06, for which your firm did not perform the can-seam tear down evaluations.
2. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas with sufficient frequency:
Maintenance of hand sanitizing facilities in that the strength of the chloride sanitizing solution was not monitored with sufficient frequency to ensure proper chlorine residuals.
Prevention of cross-contamination in that sanitation conditions and practices for the cooked crab claws was not adequately monitored to prevent cross-contamination from insanitary objects.
Protection from adulterants in that an incandescent light bulb in the ceiling of the live crab cooler that did not have a protective cover.
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 Karen Y. Dodson, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mrs. Dodson at (404) 253-1299.
Mary H. Woleske, Director