Inspections, Compliance, Enforcement, and Criminal Investigations
M. Slavin & Sons
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
April 9, 2009
WARNING LETTER NYK 2009-10
Herbert Slavin, President
M. Slavin & Sons
106 South Street
New York, NY 10038
Dear Mr. Slavin:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 800 Food Center Drive, Entrance "D", Units 37-49, Bronx, NY 10474 on February 5, 6, 9 and 11, 2009. 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 offish 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 canned crab meat and histamine producing fish species 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 follow the monitoring procedures of visually checking that ice covers your pasteurized canned crab meat products at the storage critical control point to control Clostridium Botulinum growth and toxin formation listed in your HACCP plan for pasteurized canned crab meat. Specifically, your firm was observed storing pasteurized canned crab meat without ice while displaying these products for sale. Our investigator observed a pallet load of pasteurized canned crab meat without ice being stored at ambient temperatures for approximately 8 hours. According to your HACCP plan for these products, you will ensure that the products are covered in ice during storage.
2.) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for Histamine Fish Grouping lists a monitoring procedure and frequency at the "Storage" CCP that are not adequate to control histamines. Specifically, your HACCP plan establishes a critical limit for storage temperature of these species as not exceeding (b)(4) degrees Fahrenheit; this critical limit is monitored every (b)(4) hours during operation. Your firm does not maintain temperature records when you are not in operation. Therefore, there are no temperature checks Monday through Friday from 9 am to 12 am (15 hours) and no temperature checks from 9 am Friday to 12 am Monday. (39 hours). This is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks.
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.
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 pasteurized canned crab meat at the receiving and storage critical controls points are not appropriate. Specifically, when your products are not received with ice, your corrective action states that you will take the internal temperature of these products. Taking the internal temperature of your pasteurized canned crab meat products at receipt does not ensure that the product remained at the appropriate temperature throughout transit. It is also not appropriate to check the internal temperature of your canned crabmeat when the products are not stored on ice.
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 716-541-0316.
Otto D. Vitillo