Inspections, Compliance, Enforcement, and Criminal Investigations
Cook's Seafood Company 02-Aug-07
Department of Health and Human Services
Public Health Service
Baltimore District Office
August 2, 2007
Return Receipt Requested
Mr. Eldridge N. Cook
Cook's Seafood Company
1778 Yacht Club Road
Bena, Virginia 23018
Dear Mr. Cook:
On June 11 and June 13, 2007, we inspected your seafood processing facility, located at 1778 Yacht Club Rd., Bena, VA. We found that you have serious violations from the seafood Hazard Analysis and Critical Control Points (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 Bluefish is adulterated, in that it is 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 Fishery Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
• You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP 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 Bluefish to control the food safety hazard of histamine formation.
• You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practices, to comply with 21 CFR 123.11(b). However, your firm did not adequately monitor the eight areas of sanitation conditions and practices set forth in 21 CFR.123.11(b). In addition, your firm was deficient in the following areas of sanitation conditions and practices:
1. Condition and Cleanliness of Food Contact Surfaces: The fish sorting table is constructed of unsealed wood; shovels used for placing ice on fish have wooden handles and metal blades that are cracked and pitted; the bin used to store ice used during fish packing operations is constructed of unsealed wood; the walls and ceilings of the ice room and cooler contain mold and flaking paint; the fish sorting table contains deep gouges and organic build-up including fish residues and fish scales; the shovels used for placing ice on fish during operations have dirty blades and organic build-up; the plastic strip curtains hanging in the doorway of the cooler and ice room are dirty and have organic build-up including mold; the scale used to weigh fish during packing operations contains organic build-up and fish scales; the plastic fish baskets used during packing operations are not thoroughly cleaned and sanitized prior to operations; and the plastic ice totes with stored ice in the cooler contain organic build-Lip and are not thoroughly cleaned and sanitized prior to operations.
2. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities: There is no hand washing sink or sanitizer available for employees to use prior to beginning fish packing operations.
3. Protection from Adulterants: Overhead lights in the fish packing areas and ice machine room are not protected from breaking.
4. Employee Health Conditions: Your employees are not screened daily for their health condition prior to beginning work.
5. Safety of Water: You are not monitoring for backflow prevention on hoses used in the fish processing area.
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.
Please respond in writing within 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 certification and sanitation 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: Randy F. Pack, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding any issues in this letter, please contact Mr. Pack at 410-779-5417.