Inspections, Compliance, Enforcement, and Criminal Investigations
Golub Corporation 27-May-08
Department of Health and Human Services
Public Health Service
New York District
May 27, 2008
RETURN RECEIPT REQUESTED
Neil M. Golub
CEO and President
501 Duanesburg Road
Rotterdam, New York 12306
REF: NYK 2008-12
Dear Mr. Golub:
We inspected your seafood processing facility, located at 501 Duanesburg Road, Rotterdam, New York 12306, on February 26 and 27, 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 refrigerated ready-toast seafood salad and refrigerated ready-to-eat tuna salad 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 have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR Part 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 refrigerated ready-to-eat seafood salad and refrigerated ready-to-eat tuna salad lists a critical limit, [redacted]", at the receiving critical control point that is not adequate to control pathogen growth and toxin production, and additionally, scombrotoxin formation in the tuna salad.
The various critical limit and monitor procedure options you have listed in your plan are not considered equivalent or interchangeable as safety controls in all shipping situations. Monitoring product temperatures alone at receiving is only appropriate for products that have been transported for a limited period of time (e.g., less than 4 hours) where temperature fluctuations are unlikely to affect the safety of the product. Monitoring cooling media or continuous transport temperatures is considered an adequate method of control for both short and extended transportation times. When products have been in transit for longer time periods, FDA recommends that you monitor transport conditions (e.g. adequacy of cooling media or continuous transport temperatures) to ensure that your products have been held under safe conditions throughout transport. Moreover, your plan should specify under which transport conditions a critical limit and its subsequent monitoring procedures will be used. For example, you could indicate that ice or cooling will be monitored for products received on ice or with cooling media; you could indicate that product/internal temperatures will be monitored when transit times are short (with dedicated times associated with the transit); or that products received from long distances will only be received with continuous recordings of the transit temperatures. You also have the option of eliminating your critical limit for product/ internal temperature and monitoring the adequacy of cooling media or requiring continuous time temperature data logs regardless of transit time, depending on how the products are received.
2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the receiving critical control point to control [redacted]"listed in your HACCP plan for "[redacted]" which includes ready-to-eat seafood salads. Your records indicate that you received approximately [redacted] shipments of seafood salad and [redacted] shipments of tuna salad between the dates of January 3, 2007 and February 26, 2008. However, you were not able to produce any of your monitoring records for the receipt of these shipments.
3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for ready-to-eat seafood products, which includes refrigerated tuna salad, does not list the food safety hazard of scombrotoxin formation for the refrigerated tuna salad.
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, your written HACCP plan and related 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 these 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: Lillian C. Aveta. If you have questions regarding any issues in this letter, please contact Ms. Aveta at 718-662-5576.
Otto D. Vitillo