Inspections, Compliance, Enforcement, and Criminal Investigations
Grimm's Stone Crab Inc. 03-Jun-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
June 3, 2008
Howell W. Grimm, Jr.
General Manager and Co-Owner
Grimm's Stone Crab Inc
919 Dupont Rd
Everglades City, FL 34139
Dear Mr. Grimm:
We inspected your seafood processing facility, located at 919 Dupont Rd, Everglades City, Florida 34139 on February 11-13, 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, 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 raw fish (Mackerel, Kingfish, Bluefish) and Ready-to-Eat Stone Crabs Claw 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 violations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
However, your firm's HACCP plan for "Raw Fish: Mackerel, Kingfish, Bluefish" does not list the critical control point of "Storage" for controlling the food safety hazard of histamine formation. Your HACCP plan indicates that, after packing and labeling the raw fish, you refrigerate the fish during storage. At the Storage critical control point FDA recommends monitoring holding conditions, such as adequacy of ice or monitoring cooler temperatures continuously to ensure proper temperatures are maintained to prevent histamine development.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).
However, your firm's HACCP plan for "Raw Fish: Mackerel, Kingfish, Bluefish" lists a monitoring procedure at the plan's only identified critical control point, which we have evaluated and determined to be a "Receiving" critical control point, that is not adequate to control Histamine formation. Specifically, your firm acts as a primary processor, receiving fish directly from the harvest vessels. Consequently, the monitoring procedure listed in your plan as "cook when temp type of fish" is inadequate for controlling the food safety hazard of histamine. As a primary processor, your plan needs to include controls at receiving to address the handling of the fish on-board the harvest vessels to ensure that the fish were handled safely. We suggest procedures associated with monitoring the harvest vessel records or performing histamine testing of a representative sample of fish from each lot received from the boats. In addition, we suggest monitoring for the presence of decomposition in a representative sample of fish.
3. You must maintain sanitation control records that, 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 required for the processing of Ready-to-Eat Stone Crab Claws on the safety of water that comes into contact with food or food contact surfaces; proper labeling, storage and use of toxic chemicals; control of employee health conditions, and 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 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: Winston R. Alejo, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter; please contact Mr. Alejo at (407) 475-4731
Emma R. Singleton
Director, Florida District