Inspections, Compliance, Enforcement, and Criminal Investigations
Caribbean Cold Storage, Inc 26-Apr-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 26, 2006
Julie E . Robbins, President
Caribbean Cold Storage, Inc.
1505 Dennis Street
Jacksonville, FL 32204-2003
Dear Ms. Robbins:
We inspected your seafood processing facility, located at 1505 Dennis Street on March 16- 17, 2006. We found a serious violation 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) . 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 is as follows:
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 of continuous temperature monitoring at the Receiving and Storage critical control points to control pathogen growth and toxin formation, specifically Clostridium botulinum, listed in your HACCP plan for canned pasteurized crabmeat. For example, no monitoring records were implemented for shipments received in 2006.
We acknowledge the stated corrections in your firm's response letter dated March 29, 2006 signed by your Operations Manager. However, no supporting documentation was provided to confirm any correction was implemented or if such corrections were adequate. We acknowledge your firm's intention to be in full compliance. However, we may take further action if you do not promptly correct this violation . 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 this violation. You should include in your response documentation such as HACCP 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, Attention: Shari Shambaugh, 555 Winderley Place, Suite 200, Maitland, FL, 32751. If you have questions regarding any issues in this letter, please contact Shari Shambaugh at 407-475-4730.
Emma R . Singleton
Director, Florida District