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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pierino Frozen Foods, Inc. 1/10/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Detroit District Office
300 River Place, Suite 5900
Detroit, MI 48207-3179
Telephone: 313-393-8100
FAX: 313-393-8139


January 10, 2013
VIA UPS                               
Gianni M. Guglielmetti, Vice President
Pierino Frozen Foods, Inc.
1695 Southfield Road
Lincoln Park, Michigan 48146-2275
Dear Mr. Guglielmetti:
We inspected your seafood processing facility located at 1695 Southfield Road, Lincoln Park, Michigan, on November 7-8, 20, and 29, 2012We 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 CFR 123). 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 Gourmet Crab Ravioli and Lobster Ravioli 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: 4th Edition – April 2011 through links on 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 and fishery product that 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 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for Gourmet Crab Ravioli and Lobster Ravioli products to control the food safety hazards of Clostridium botulinum formation and metal inclusion.
Specifically, you thaw unopened, vacuum-packed packages of frozen crab and lobster meats for (b)(4) hours at a temperature of approximately (b)(4)F. You have not identified the hazard of Clostridium botulinum which is reasonably likely to occur during this thawing step. You were cited for this same observation on an FDA Form 483 which was issued at the conclusion of an inspection on February 12, 2010. 
You also did not identify the hazard of metal inclusion which is reasonably likely to occur during the preparation of your lobster and crab meat fillings used in your Gourmet Crab Ravioli and Lobster Ravioli products. 
We acknowledge receipt of your letter, dated December 13, 2012, which was sent in response to the FDA Form 483 issued on November 29, 2012. Your response letter is inadequate because these hazards were not addressed and a written HACCP plan was not presented. 
Chapter 13 of the Fish and Fisheries Products Hazards & Controls Guidance can provide guidance related to the hazard Clostridium botulinum and vacuum packed seafoods. With your response, you included a table for the following processing steps: “Stuff or Form” and “Cook”. This table indicates that your cook step “(b)(4)”. The crab and lobster meats which you use in your ravioli are not raw; they are purchased already cooked, vacuum packed, and frozen prior to thawing. The Guidance indicates that, while Clostridium botulinum toxin can be destroyed by boiling for 10 minutes, boiling should not be relied upon as a means of control because of the potency of the toxin.   
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 current monitoring procedures for Gourmet Crab Ravioli and Lobster Ravioli do not include sufficient controls as follows:
You do not monitor the temperature of your refrigerator with sufficient frequency, to include weekends, to ensure that the temperature is maintained at a minimum of (b)(4)F, during the thawing of frozen crab and lobster, to control the hazard of Clostridium botulinum.  FDA recommends that the temperature be continuously monitored during the thawing process. 
3.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.6(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for hand washing, hand sanitizing, and toilet facilities; proper labeling, storage, and use of toxic compounds; and control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces. 
Your response letter included Sanitation Standard Operating Procedure (SSOP) check sheets. Your response was inadequate because the SSOP check sheets do not include these records. You were cited for this same observation on an FDA Form 483 which was issued at the conclusion of an inspection on February 12, 2010.
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 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 and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 re-inspection 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please send your reply to the Food and Drug Administration, Attention: Tina M. Pawlowski, Ph.D., Compliance Officer, Detroit District Office. If you have questions regarding any issues in this letter, please contact Compliance Officer Pawlowski at (313) 393-8217.
Glenn T. Bass
District Director
Detroit District