Inspections, Compliance, Enforcement, and Criminal Investigations
Maria's Fresh Seafood Market, L.L.C. 22-Oct-08
Department of Health and Human Services
Public Health Service
555 Winderley Place, Ste. 200
Telephone: (407) 475-4700
RETURN RECEIPT REQUESTED
October 22, 2008
Scott J. Amberson, Owner
Maria's Fresh Seafood Market, L.L.C.
621 E. Cervantes St.
Pensacola, Florida 32501-3207
Dear Mr. Amberson:
We inspected your seafood processing facility, located at 621 E. Cervantes St., Pensacola, FL 32501-3207 on June 16, 2008. 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 Fresh Cooked Crabmeat, Pasteurized Canned Crabmeat, and Fresh Whole Tuna, 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 or, fishery product 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 to occur, to comply with 21 C.F.R. § 123.6(a) and (b). However, your firm does not have HACCP plans for:
• fresh, cooked crabmeat, to control the potential food-safety hazards of pathogen growth.
• canned, pasteurized crabmeat to control the potential food-safety hazards of pathogen growth and Clostridium boculinum toxin formation.
2. 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 "Tuna" lists a monitoring procedure at the "Receiving" critical control point that is not adequate for controlling the food safety hazard of histamine formation. Specifically, the monitoring procedure does not provide sufficient information as to "What" will be monitored. When a firm chooses to only monitor the temperature at the time the products are received, FDA recommends monitoring "The internal temperature of a representative number of fish in the lot at the time of delivery." In addition, monitoring the internal temperature of the product at the time of delivery is only adequate for fish delivered refrigerated (not frozen), with a transit time of four hours or less. If the transit time is more than four hours, FDA recommends a means to continuously monitor the internal temperature of the fish, or the carrier, throughout the entire transportation period. Alternative, a firm could monitor the adequacy of ice at Receiving: It appears that your firm is actually monitoring the adequacy of ice at Receiving in addition to monitoring the internal temperature of the product. If you choose to monitor the adequacy of ice rather than internal temperature of the product, or the continuous internal temperature of the product or carrier, throughout transportation, FDA recommends a critical limit of "There is an adequate quantity of ice or other cooling media at the time of delivery to completely surround the product" and a monitoring procedure that monitors "The adequacy of ice or chemical cooling media at the time of delivery" using a method of "Make visual observations of the adequacy of ice or other cooling media in a sufficient number of containers (e.g. cartons, totes, etc.) to represent all of the product" for "Every lot received"
• Additionally, your firm's HACCP plan for "Tuna" lists "a monitoring procedure at the "Storage" critical control point that is not adequate for controlling the food safety hazard of histamine formation. Specifically, the monitoring method and frequency are not appropriate. FDA recommends that you measure the temperature of the cooler using a continuous method such as "Use a digital time/temperature data logger," "Use a recorder thermometer," or "Use a high temperature alarm within 24 hour monitoring" with a frequency of "Continuous monitoring by the instrument itself, with visual check of the instrument at least once per day." Alternative, a firm could monitor the adequacy of ice during Storage. It appears that your firm is actually storing your finished product under ice. If you choose to monitor the adequacy of ice rather than temperature of the cooler, FDA recommends-a critical limit of "Product completely cover by ice throughout storage" and a monitoring procedure that monitors "The adequacy of ice surrounding the product" using a method of "Make visual observations of the adequacy of ice or other cooling media in a sufficient number of containers (e.g. cartons, totes, etc.) to represent all of the product" with a frequency of "At least twice per day" and "At least immediately prior to shipment."
3. 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 plan for "Tuna" at the critical control point of "Receiving" and "Storage" does not include appropriate corrective actions for temperature deviations such as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation.
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: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Director, Florida District
cc: Raymond W. Boyer