Inspections, Compliance, Enforcement, and Criminal Investigations
Woodge Inc. DBA Mr. Fish
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Atlanta District Office
60 Eighth Street, NE
Atlanta, GA 30309
January 6, 2009
VIA FEDERAL EXPRESS
Theodore Hammerman, President/Owner
Woodge, Inc. dba Mr. Fish
1515 Cannon Rd.
Myrtle Beach, SC 29577
Dear Mr. Hammerman:
We inspected your seafood processing facility, located at 1515 Cannon Rd on 10/22/2008. 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 (21 CFR 123). 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 refrigerated pasteurized crabmeat and frozen fishery 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 violation was as follows:
• 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 you must have and implement a written HAACP plan to control any food safety hazards that 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 refrigerated pasteurized crabmeat to control the food safety hazards of pathogen growth and toxin formation. Your firm will likely need to include in your HACCP plan, the critical control points of receiving and refrigerated storage to control pathogens.
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: Serene N. Ackall, Compliance Officer at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Serene N. Ackall at 404-253-1296.
Barbara A. Wood
Acting District Director