Inspections, Compliance, Enforcement, and Criminal Investigations
L.P. Wholesale Seafood, Ltd. 5/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Avenue
Jamaica, NY 11433
May 7, 2009
WARNING LETTER NYK 2009-12
Louis R. Pirilli, President
L.P. Wholesale Seafood, Ltd.
295 Midland Ave.
Port Chester, NY 10573
Dear Mr. Pirilli:
We inspected your seafood processing facility, located at on 295 Midland Ave., Port Chester, NY 10573 on January 5, 6 and 8 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 ready-to-eat pasteurized crabmeat and ready-to-eat vacuum packaged cold smoked salmon 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 procedure of recording the critical limits at the receiving
critical control point for you to control Clostridium botulinum listed in your HACCP
plan for ready-to-eat pasteurized crabmeat and ready-to-eat vacuum packaged cold
Specifically, according to your firm's "Daily Buy Sheets" your firm received ready-to-eat
pasteurized crabmeat on October 2,10,30 and 31 of 2008, November 19, 2008, and
December 31,2008 and ready-to-eat vacuum packaged cold smoked salmon on October
10, 13,27,30 and 31 of2008, and December 4, 15, 18, and 31 of 2008. However, your
firm does not have any monitoring records that document the temperature at the receiving
critical control point for these products as stated in your HACCP plan. Further, the
investigator was informed by your manager that these products are not checked for
temperature upon receipt.
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 ready-to-eat pasteurized crabmeat and ready-to eat
vacuum packaged cold smoked salmon lists a monitoring procedure and frequency at
the "Storage" CCP that are not adequate to control pathogen growth and toxin formation.
Specifically, your HACCP plan establishes a critical limit for storage temperature of
these species as not exceeding (b)(4) Fahrenheit; this critical limit is monitored (b)(4) daily during operations. Your firm does not maintain temperature records when you are not in operation. Therefore, there are no temperature checks Monday through Saturday from 4 pm to 7am (15 hours) and no temperature checks from 4 pm Saturday to 7 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
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 written reply to the Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding this letter, please contact Mr. Rugnetta at 716-541-0316.
Otto D. Vitillo