Service Smoked Fish Corp 5/10/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District Food & Drug Administration 158-15 Liberty Avenue Jamaica, NY 11433

May 10, 2010

WARNING LETTER NYK 2010-11

VIA UNITED PARCEL SERVICE

Jay Wiener, President

Service Smoked Fish Corp.

54 Throop Avenue

Brooklyn, NY 11206-4307

Dear Mr. Wiener:

We inspected your seafood processing facility, located at 54 Throop Avenue, Brooldyn, NY, on November 5 - 27, 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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, also renders your fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Accordingly, your cold smoked, ready-to-eat seafood products 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 and Controls Guidance through links in FDA's home page at www.fda.gov.

Further review of your HACCP plan revealed the following significant violations:

• 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "Cold Smoked Seafood Products" does not list a critical control point for thawing of the frozen fish to control pathogen growth. Specifically, our investigator noted that your firm receives frozen fish and conducts a thawing process prior to brining and cold smoking. This thawing process was described as (b)(4). Since this thawing process is conducted over an extended time period, when the fish are unfrozen, this process is a necessary critical control point because in the absence of time and temperature controls pathogen growth is a reasonably likely hazard. Moreover, FDA recommends strict temperature controls at or below 40°F, with continuous monitoring. Consequently, we suggest that your firm adopt procedures that include continuously monitoring and recording of both time and temperature, to ensure that appropriate temperatures were maintained for the entire duration of the thawing process. We further recommend a review of the monitoring record, prior to any subsequent processing of that lot of fish, to ensure that the fish have not been exposed to time and temperature abuse conducive to pathogen growth.

•You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123(c)(4). However your firm's HACCP plan for "Cold Smoked Fish Products" does not list adequate monitoring procedures/frequencies at the "cold-smoke" critical control point to control "growth of bacterial pathogens in finished product; C. botulinum toxin production in finished, vacuum-packed". Specifically, your plan lists that you will (b)(4) in not adequate to ensure that proper temperatures were maintained for the entire duration of the cold smoke process, FDA recommends continuous monitoring and recording of time and temperatures for the entire duration of the cold smoke process to ensure that each fish achieves an adequate smoke process.

During this inspection FDA investigators collected two samples of finished cold smoked nova salmon (samples 554949 and 554950) and an environmental sample (INV 554948). As you are aware, FDA analyses of those samples revealed presence of the bacteria Listeria monocytogenes (L.M). Further analyses, via pulse field gel electrophoresis (PFGE) indicated the strains of L.M found in the finished product samples were indistinguishable from the strains found in the environmental samples. Finding that the strains are indistinguishable is evidence that links the environment as a source or vehicle for the finished product contamination.

We acknowledge your November 19, 2009 voluntary recall and destruction of cold salmon nova salmon produced between November 1-18, 2009. Additionally, 2009 response letter in which you indicate firm has or will institute corrections in the form of training, cleaning, and sampling. While we acknowledge these intended corrective actions, your firm should continue to perform appropriate cleaning and sampling and should consider adopting an L.M. sampling and monitoring program on a regular basis to prevent similar future situations.

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 plan 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: Patricia A. Clark, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Ms. Clark at 716-551-4461, ext. 3168.

Sincerely,

/s/

Ronald M. Pace

District Director

New York District

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