Inspections, Compliance, Enforcement, and Criminal Investigations
Double D Seafood Company LLC 13-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|555 Winderley Pl., Ste. 200 |
Maitland, FL 32751
September 13, 2005
RETURN RECEIPT REQUESTED
Matthew R. Loder Sr., President and Owner
Double D Seafood Company LLC
1830 3`d Avenue South
St. Petersburg, FL 33712
Dear Mr. Loder:
We inspected your seafood processing facility, located at the above address on August 15 and 16, 2005. 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 histamine-forming fish, canned pasteurized crabmeat, ready-to-eat stone crab claws 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 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 HACCP plan to control any food safety hazards that are reasonably likely occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for canned pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation, specifically, Clostridium botulinum, and for ready-to-eat stone crab claws to control the hazard of pathogen growth and toxin formation. We previously brought this same objection to your attention in our letters dated August 12, 2002 and August 29, 2002 reviewing the need for HACCP plans for several other species of fish.
2. 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 Receiving or Storage critical control points to control the hazard of histamine formation listed in your HACCP plan for Scombroid Species.
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 for the eight areas of sanitation identified in that section including: safety of water, prevention of cross-contamination, maintenance of hand washing, hand sanitizing and toilet facilities, protection from adulterants and exclusion of pests required for the processing of fishery products, such as ready-to-eat cooked stone crab claws. During our inspection, your firm was not maintaining any sanitation corrections records at least since April 2005.
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 monitoring 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, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Compliance Officer, Shari H. Shambaugh. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton,
Director, Florida District