| Public Health Service Food and Drug Administration |
New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human ServicesNovember 8, 2010
WARNING LETTER NYK-2011-6
VIA U.P.S.
Anthony Mazzela, President
Tony Crab King, Inc.
800 Food Center Drive, Unit # 93
Bronx, New York 10474
Dear Mr. Mazzela:
We inspected your seafood processing facility, located at 800 Food Center Drive, Unit # 93, Bronx, New York between June 23 and July 6, 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 refrigerated ready-to-eat (RTE) canned crabmeat, cooked seasoned crab claws, and oysters 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 a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for RTE cooked seasoned crab claws to control the food safety hazard of pathogen growth when you receive, store, and display this product for sale.
2) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points to comply with 21 CFR § 123.6(c)(3). A critical limit is defined in 21 CFR § 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for “Pasteurized Crab Meat” does not list the critical limit the “Receiving” Critical Control Point (CCP) to control pathogen growth, including but not limited to, Clostridium botulinum.
3) You must implement the monitoring procedures and record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6 (b). However, your firm did not follow the monitoring procedure and frequency of (b)(4) for (b)(4) record at the display CCP to control pathogen growth listed in your HACCP plan for canned pasteurized crab meat. Furthermore, our Investigators observed your firm using (b)(4) in attempt to control the temperature at this CCP, and (b)(4) the (b)(4). The procedure of using (b)(4) as a cooling media with (b)(4) is not adequate to control pathogen growth at the display CCP. The visual checks of the (b)(4) can not determine whether the product’s temperature is under control.
In addition, you must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6 (b). However, your firm did not record the monitoring observations at the receiving CCP to control pathogen growth listed in your HACCP plan for canned pasteurized crab meat. Specifically, your firm does not maintain a (b)(4) listed in your “Pasteurized Crab Meat” HACCP plan for the receiving CCP, or any other record to show the temperature of the canned pasteurized crab meat upon receipt.
4) To comply with 21 CFR 123.6(c)(4), you must have a HACCP plan that, at minimum, lists appropriate monitoring procedures for each critical control point. However, your firm’s HACCP plan for the canned pasteurized crab meat lists monitoring frequencies at the storage critical control points that are not adequate to control pathogen growth, including but not limited to, Clostridium botulinum. Specifically, your monitoring frequency of (b)(4) for the cold storage CCP is not appropriate to determine that the critical limit is being met when your firm is not in operation. Furthermore, our Investigators observed that you only monitor the cooler temperature (b)(4) per day.
FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly. FDA recommends that you check the adequacy of ice or cooling media at least twice per day.
5) Since you chose to include corrective actions 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 RTE pasteurized canned crab meat at the cold storage and display critical control points to control the hazard of pathogen growth are not appropriate. The corrective action (b)(4) for the cold storage CCP does not ensure that adulterated product will not be distributed or that the cause of the deviations was corrected. Furthermore, the corrective action (b)(4) for the display CCP does not ensure that the cause of the deviation was corrected, or provide any action to determine whether held products is adulterated.
6) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR § 110, to comply with 21 CFR § 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces with sufficient frequency and adequately prevent cross contamination with insanitary objects to ensure compliance as evidenced by:
Condition and cleanliness of food contact surfaces
a) On June 23, 24, and 25, 2010, our Investigators observed a white plastic cutting board on top of a stainless steel processing table in the front area of your stall with several deep gouges and dark grime in the gouges. These gouges prevent the cutting board from being properly cleaned and sanitized;
b) On June 23, 24, and 25, 2010, our Investigators observed your ready-to-eat cooked seasoned crab claw being displayed in a cardboard shipping box on a wet display counter, adjacent to ready-to-eat shellfish, raw fin fish and raw shucked shellfish. Cardboard shipping boxes cannot be properly maintained, cleaned or sanitized and provide the potential for biological, physical and chemical contamination to your ready-to-eat cooked seasoned crab claw;
Prevention of cross contamination
c) On June 23, 24, and 25, 2010, our Investigators observed a cardboard shipping carton containing cooked seasoned crab claw on the same display table adjacent to raw fish and raw clams. Raw and cooked foods must be segregated from each other to avoid the hazard of cross contamination;
d) On June 23, 24, and 25, 2010, our Investigators observed your walk-in cooler to have accumulating condensate on the ceiling near the blower unit. This condensate was observed dripping directly on raw ready-to-eat oysters stored directly underneath it. Condensate may contain physical, biological and/or chemical hazards; and
e) On June 23, 24, and 25, 2010, our Investigators observed an uncovered apparent dirty overflowing dumpster located in your walk-in cooler directly adjacent to raw ready-to eat clams and oyster.
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 Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Mr. Rugnetta at 716-541-0324.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
cc: Thomas Walsh, Manager
Tony Crab King, Inc.
800 Food Center Drive, Unit # 93
Bronx, New York 10474
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