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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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JLM Manufacturing LLC 5/21/13


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

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


May 21, 2013
Mr. Thorn Lipari, President/CEO
JLM Manufacturing, LLC.
14285 Frazho Road
Warren, MI 48089
Dear Mr. Lipari:

We inspected the seafood processing operations at your facility located at 14285 Frazho Road, Warren, Michigan on March 25 and 27, 2013 and April 3, 9 and 10, 2013.  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 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 Tuna Salad Sandwiches 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: 3rd Edition (the Hazard Guide), through links in FDA's home page at www.fda.gov.
We received a response from Spiro Liras, Manufacturing Director, on May 3, 2013, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm.  We address this response below, in relation to each of the noted violations.
The violations found during the inspection and subsequent review includes, but are not limited to, the following:
1.    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(b). However, from March 6, 2013 through March 26, 2013, during the manufacture of Tuna Salad Sandwiches, your firm failed to implement monitoring, verification and recordkeeping procedures listed in your HACCP plan to control the hazards of Histamine and Clostridium botulinum.  Additionally, your firm failed to implement the monitoring, verification and recordkeeping procedures listed in your HACCP plan to control food allergens and additives for five of ten days reviewed to include: January 7, 2013, February 7, 2013, March 6, 2013, March 14, 2013, and March 25, 2013.
Your firm's response, received on May 3, 2013, is not adequate.  Your firm did not include documentation or evidence of implementation of the corrections or corrective actions.
2.    You must maintain sanitation control records that, at a minimum document monitoring and corrections to comply with 21 CFR123.11(c).  However, your firm did not maintain sanitation monitoring records required for the processing of Tuna Salad Sandwiches, including:
a.  The safety of the water;
b.  The prevention of cross-contamination;
c.  The maintenance of hand washing, sanitizing and toilet facilities;
d.  The protection of food and food packaging materials;
e.  The proper labeling, use and storage of toxic chemicals;
f.   The control of employee health;
g.  The exclusion of pests.
Your firm's response, received on May 3, 2013, is not adequate.  Your firm did not include documentation or evidence of implementation of the corrections or corrective actions.
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 there as on 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).  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 U.S. Food and Drug Administration, Attention: CDR Kimberly Martin, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207.  If you have questions regarding any issues in this letter, please contact CDR Martin at (317) 226-6500 ext. 116.
Glenn T. Bass
District Director
Detroit District Office