Inspections, Compliance, Enforcement, and Criminal Investigations
Bacalao Brothers, Inc. dba New England Fish Market 10/20/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
October 20, 2011
John H. Mellaci (Owner)
Bacalao Brothers, Inc.
dba New England Fish Market
1419 N.E. Jensen Beach Blvd
Jensen Beach, FL 34957
Dear Mr. Mellaci:
We inspected your seafood processing facility, located in Jensen Beach, FL from July 25-26, 2011. 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 (21 CFR 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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 pasteurized crab meat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However,
• Your firm’s revised HACCP plan for pasteurized crab meat, dated 8/1/2011, references the monitoring of TTIs at the “Receiving” and “Storage” critical control points to control Clostridium botulinum growth. However, FDA does not recommend relying on TTIs as a strategy for monitoring temperatures of products at receiving and during storage. FDA only recommends the use of TTIs for the consumer or end user. Moreover, the TTI devices would need to have been affixed and activated by the primary processor from whom you receive the products. The TTI is not, however, intended as a substitute for monitoring temperatures during transit and storage to ensure that products have not been exposed to conditions conducive to Clostridium botulinum toxin formation.
• Your firm’s revised HACCP plan for pasteurized crab meat, dated 8/1/2011, lists a monitoring procedure at the storage critical control point that is not adequate to control Clostridium botulinum. Specifically, monitoring storage temperatures “2 times per day” is not adequate to ensure that proper temperatures were maintained between the twice daily checks (i.e., between the 12 hour lapses between checks) and does not ensure that temperatures will be monitored when your firm is not in operation such as during weekends and holidays. Additionally, with regard to your firm’s reference to monitoring “crab is stored on ice” your plan does not list any corresponding monitoring procedures associated with monitoring for the presence of adequate ice surrounding the products.
Please be advised that when monitoring storage temperatures, FDA recommends the use of equipment capable of continuously monitoring time and temperature on a 24 hour a day/7 day a week basis with a minimum of once daily checks of the recorded data.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for pasteurized crabmeat at the receiving and storage critical control points (CCPs) to control the hazard of Clostridium botulinum are not appropriate. Specifically,
• Your corrective actions listed at the “Receiving” critical control points are inadequate because your firm will be unable to implement the actions. Specifically, because your firm is monitoring the presence of adequate ice covering the shipments, your firm will not be capable of taking any action based on “…temp above 38 degrees f for more than three hours”. Your firm not monitoring temperatures or times during transit, consequently your firm will not have the time and temperature parameters necessary to make a determination regarding the safety of the products. In addition, the action listed as “re-cook” is not appropriate as re-cooking potentially adulterated product, particularly in products that pose a hazard for Clostridium botulinum toxin is not an adequate corrective action.
• Your corrective action listed as “re-ice” products at the “Storage” critical control point is inadequate because receiving products that have already been temperature abused during storage does not address the cause of the deviation or prevent the distribution of potentially adulterated and unsafe products (i.e., products that have already been abused prior to re-icing to lower the temperatures).
We received your letter dated August 1, 2011, responding to the Form FDA 483, Inspectional Observations, issued to you on July 26, 2011. Your response does not adequately address the significant observations noted on the Form FDA 483. We have reviewed your revised HACCP plan for your pasteurized crabmeat as described above. Additionally, you did not address the implementation of your sanitation monitoring.
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 U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.
Emma R. Singleton
Director, Florida District