Inspections, Compliance, Enforcement, and Criminal Investigations
Florida's Finest Seafood Company 4/3/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
April 3, 2012
Mr. Gregg Jaffy
Florida’s Finest Seafood Company
3628 N.W. 16th Street
Lauderhill, Florida 33311
Dear Mr. Jaffy:
We inspected your seafood processing facility, located at 3628 N.W. 16th Street, Lauderhill, Florida 33311 on February 28 and 29, March 1, 2, 5, 6 and 8, 2012. 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 fish and fishery products, including but not limited to histamine forming fish, pasteurized crabmeat, and smoked salmon 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:
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."
- However, your firm’s HACCP plan for Pasteurized Crabmeat does not list a critical limit at the Cooler Stage critical control point to control Pathogenic Bacteria Growth, C. Botulinum Growth, or Toxin formation. Further, your firm’s HACCP plan for Histamine Producing Fish lists critical limits , “No histamine producing species will be received with inadequate ice”, at the Receiving critical control point and of “Histamine producing species will not exceed 40 degrees for more than four hours cummutively”, at the Cooler Storage critical control point, that are not adequate to control Scombrotoxin formation as there is no definition of adequate ice and the cooler temperatures were observed to be above 40ºF at various times throughout the inspection.
- 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(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 Smoked Salmon does not list the critical control point of Thawing for controlling the food safety hazards of Pathogenic Bacteria Growth/Temperature Abuse and C. Botulinum Toxin formation.
- You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).
- However, your firm did not follow the monitoring procedures and frequency as described in your “Recorded Temp Log of Cooler” and “Printout of Thermometer Records” for the Cooler Stage critical control point to control Pathogenic Bacteria Growth, C. Botulinum Growth, or Toxin formation, listed in your HACCP plans for Pasteurized Crabmeat and Smoked Salmon.
- 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 Pasteurized Crabmeat does not list the monitoring procedures at the Cooler Storage critical control point to control Pathogenic Bacteria Growth, C. Botulinum Growth, or Toxin formation. Additionally, your firm’s HACCP plan for Histamine Producing Fish lists a monitoring procedure at the Receiving critical control point that is not adequate to control Scombrotoxin formation.
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7).
- However, your firm did not record monitoring observations at the Cooler Storage critical control point to control Pathogenic Bacteria Growth, C. Botulinum Growth, or Toxin formation, listed in your HACCP plan for Pasteurized Crabmeat.
- You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a).
- However, your firm did not verify the adequacy of the critical limit of temperature for Histamine Producing Fish, Pasteurized Crabmeat and Smoked Salmon at the Cooler Storage and Receiving critical control points to control Scombrotoxin formation, Pathogenic Bacteria Growth, or C. Botulinum Growth.
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: Ms. Andrea Norwood, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norwood at 407-475-4724.
Emma R. Singleton
Director, Florida District