Inspections, Compliance, Enforcement, and Criminal Investigations
Ginsberg's Institutional Foods, Inc. 2/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
February 14, 2012
WARNING LETTER NYK-2012-11
VIA UNITED PARCEL SERVICE
Mr. David M. Ginsberg, President
Ginsberg's Institutional Foods, Inc.
Route 66, 29 Ginsberg Lane
Hudson, NY 12534
Dear Mr. Ginsberg:
We inspected your seafood processing facility, located at Route 66, 29 Ginsberg Lane, Hudson, NY 12534 on December 6, 2011 through December 9, 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 C.F.R. 123). In accordance with 21 C.F.R. 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 tuna salad, shrimp salad, seafood salad, herring fillets in wine sauce, vacuum packed smoked salmon and histamine forming fish (including, but not limited to tuna, marlin, escolar, wahoo and mahi) 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.
We received your firm's response dated December 19, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to John J. Grossman, Operations Manager/HACCP Coordinator. We address this response below, at the conclusion of the noted violations. The violations include, but are not limited to, the following:
1. You must have a HACCP plan that, at a minimum, lists the food 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 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."
Monitoring critical limits for Clostridium botulinum, pathogen growth and histamine formation at a receiving step falls into two categories: 1) 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 the internal product temperature is adequate, and 2) For products that have been in transit for longer time periods (e.g., more than 4 hours) FDA recommends that you monitor transport conditions (e.g. adequacy of cooling media along with internal product temperature, monitoring for the adequate presence of ice, or continuous transport temperatures) to ensure that your products have been held under safe conditions throughout transport. Furthermore, you may elect to use the monitoring for products that have been in transit for longer time periods (e.g., more than 4 hours) to monitor all of the products indicated in this violation, as it is more stringent, and would adequately monitor the products regardless of the duration of the transit time. Your firm's HACCP plans identified below are inadequate for products that have been in transit for longer time periods (e.g., more than 4 hours) as follows:
• Your seafood/shrimp/tuna salad HACCP plan only lists critical limits of internal temperature or ambient truck temperature at or below 40°F at the receiving step. This does not ensure the control of Clostridium botulinum, pathogen growth or histamine formation.
• Your histamine-forming fish HACCP plan only lists critical limits of ice or internal temperature of <40°F at the receiving step. This does not ensure the control of histamine formation.
• Your HACCP plan, which includes smoked salmon vac-pac (vacuum packaged), only lists critical limits of internal temperature or ambient truck temperature at or below 38°F at the receiving step. This does not ensure the control of Clostridium botulinum and pathogen growth.
2. You did not take corrective action to ensure that affected product was not entered into commerce, to comply with 21 C.F.R. 123.7 (a). For example, audit of the seafood/shrimp/tuna salad HACCP plan lists a receiving step corrective action of "reject product if temperature above 40°F". Two shipments of tuna salad, one received on 7/13/10 and the other received on 7/25/11 exceeded 40°F without your firm rejecting the shipments.
3. Your HACCP plan does not list the food safety hazards that are reasonably likely to occur, to comply with 21 C.F.R. 123.6 (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." For example, your HACCP plan for the Herring Fillets in Wine Sauce failed to identify the significant hazard of histamine formation.
4. You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process, to comply with 21 C.F.R. 123.6 (a). Your firm does not have a HACCP plan to control the significant hazard of histamine in the fresh escolar and wahoo you distribute.
5. Your HACCP plan includes a corrective action plan that is not in accordance with 21 C.F.R. 123.7(b) to ensure affected product is not entered into commerce, to comply with 21 C.F.R. 123.6 (c)(5). For example, an audit of the HACCP plan for histamine forming fish, lists under corrective action "noticed, temp will be taken and if product above 40°F reject". This does not ensure the control of histamine formation in products received from suppliers with over a four (4) hour transit time. For example your firm's suppliers for histamine-forming fish are located in Boston, Massachusetts which could reasonably be over a four (4) hour transit time. Additionally, an audit of your HACCP plans for histamine-forming fish, "smoked fish", and seafood/shrimp/tuna salads revealed that the corrective action sections, for both receiving and storage, only identify product disposition and fail to identify how the cause of the deviation is to be corrected.
Your firm's response to the aforementioned violations is inadequate. Your response is simply a promise to correct the violations. For example, your response states that your firm is currently working on having your HACCP plans revisited and updated, but no timeframe for completion was given. Additionally, no indication was given to what immediate actions have been taken to ensure that products are not being adulterated in this interim time period until proposed corrections are completed and implemented. Your firm's response also indicates that employees will be re-trained in response to the observations, but no training documentation was submitted at the time of the response. Furthermore, as of January 20, 2012, no additional documentation has been submitted.
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 C.F.R. Part 123) and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulation.
Section 743 of the Act (21 U.S.c.379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be sent the Food and Drug Administration; Attention:
LCDR Frank Verni
U.S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: LCDR Frank Verni at (718) 662-5702.
Ronald M. Pace
New York District