Department of Health and Human Services
Public Health Service
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
November 10, 2010
Julio R. Rosell
Friz-it Cold Storage, Inc.
5900 N. W. 97th Avenue, Suite #17
Miami, FL 33178
Dear Mr. Rosell:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at the above address on July 7-13, 2010. 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 scombroid fish, canned pasteurize crab meat, and your fresh ready to eat crab meat 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 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
a) follow the monitoring procedure(s) frequency of 24 hour continuous monitoring at the storage critical control point to control histamine formation listed in your two separate HACCP plans identified as "histamine producing fish".
b) perform a daily check for accuracy of your continuous recording thermometer as stated in your HACCP plan for "histamine producing fish".
c) check the adequacy of ice at the storage CCP as stated in your HACCP plans for "Fresh fish with the potential hazard of histamines".
2. Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate in order to comply with 21 CFR 123.7(h). However. your corrective action plan for the storage critical control point in your HACCP plan for "Fresh fish with the potential hazard of histamines" which states "if temperature is too high, close door to the cooler" is inadequate because it does not address how the problem will be corrected and how affected product will be handled. In addition, the HACCP plan states, "If temperature exceeds 40 degrees F for four hours, reject lot or analyze 10% from the lot including fish from the portions of the lot above temperature. If one fish sample is above 50 ppm histamine, reject lot or sub-divide lot (if practical) and retest." This corrective action is inadequate because analyzing 10% of the lot does not ensure that fish that were temperature abused were not introduced into commerce. Refer to Chapter 7 "Histamine" of the Fish & Fisheries Products Hazards & Controls Guidance: Third edition for assistance.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District