On March 22, the U.S. Food And Drug Administration released this March 10 letter regarding to the presence of Listeria at its facility.

Dear Mr. Koifman:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility located at 738 Chester Street, Brooklyn, New York on October 20 through November 3, 2009, and collected a variety of samples, including finished products, in-process product samples, and environmental swabs. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes) in your facility. In addition, FDA investigators observed 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 and 110]. These violations and the positive environmental L. monocytogenes results cause your ready-to-eat cured and smoked fish products to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, your firm’s improper use of an anti-microbial chemical, as described below, causes your food to be adulterated within the meaning of 402(a)(2)(c), in that it bears or contains a food additive that is unsafe within the meaning of section 409 of the Act. You can find the Act, the seafood HACCP regulation, the Current Good Manufacturing Practice regulation for foods and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov. L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening, illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions. Four environmental swabs collected from your facility tested positive for L. monocytogenes. These swabs were collected from: a floor/wall junction adjacent to the brining refrigerator door in the cutting/cleaning room; a refrigerator guide bracket in the rinsing/hanging room; the surface and interior of the round drain at the center of the cutting/cleaning room floor; and the surface of the L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated.hed product becoming contaminated.

L. monocytogenes has been detected by environmental swabs in your facility during previous FDA inspections conducted between May 27 and June 3, 2009 (60 positive swabs) and September 10 and September 26, 2008 (10 positive swabs). During our previous inspections of your facility, finished product samples of your vacuum packaged smoked salmon and salted herring products tested positive for L. monocytogenes. We acknowledge that your firm voluntarily recalled and voluntarily destroyed the affected product, and on request of the New York State Department of Agriculture and Markets, stopped all production in an attempt to clean and sanitize your facility and remove any L.monocytogenes. Based on the most recent FDA inspection, however, it is apparent that L. monocytogenes continues to reside your facility. Once established in a production area, humans or machinery can facilitate the pathogen’s movement to and contamination of food-contact surfaces and finished product. These repeat findings of environmental and finished product positives demonstrate an inability to adequately clean and sanitize the facility and to correct practices that lead to the contamination of finished product with L. monocytogenes.

In addition, during our most recent inspection, our investigators observed your employees using (b)(4) antimicrobial solution (b)(4) directly in the brining solution, spraying it directly on in-process seafood products during drying, and directly on seafood products and packaging materials during packaging. According to 21 CFR §§ 173.370 and 173.315, this product may only be safely used at the prescribed concentrations on meat and poultry, and to assist in the peeling of fruits and vegetables; there is no regulation for use in seafood and its use is not general recognized as safe as defined in Section 409 of the Act. FDA investigators also observed the following significant violations of the seafood HACCP regulation and the Current Good Manufacturing Practice regulation for foods [21 CFR §§ 123 and 110]:

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 procedures or frequencies at the "Storage of finished product" critical control point listed in your "Refrigerated, vacuum-packaged, cured, cured! smoked ready-to eat fish" HACCP plan. Specifically, your HACCP plan states that you will continuously monitor storage temperature to ensure that it is (b)(4) or lower to control the hazard of pathogen growth including Clostridium botulinum,however, your firm only monitors cooler temperatures (b)(4).This does not ensure compliance with your critical limit when your firm is not in operation.

2) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR §§ 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the following critical control points listed in your "Refrigerated, vacuum packaged, cured, cured/ smoked ready-to-eat fish" HACCP plan:

• For the critical control point of "Receiving Scrombroid Sp.," your HACCP plan identifies three critical limits that you did not monitor, including: (b)(4). For example, your receiving log sows that you did not have any of the associated HACCP records stated above for the receipt of: escolar on September 18, and July 15, 2009; and herring on September 22, August 11 and 21, July 7 and 27, 2009.

• For the critical control point of "Fish with the hazard of parasites and to be cold smoked," you did not have records to show whether the fish were held at (b)(4). Specifically, your HACCP plan identifies salmon to have the significant hazard of parasites, and the receiving log shows you received salmon on numerous occasions between July and September of 2009, including but not limited to, September 30, August 25, and July 14, 2009. Yet, you did not maintain a record of time and temperature control from the supplier to show that the fish were held at (b)(4).

3) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points to comply with 21 CFR § 123.6(c)(3). A critical limit is defined in 21 CFR § 123.3(c) as "the maximum ·or minimum value 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." However your firm’s HACCP plan for "Refrigerated, vacuum-packaged, cured, cured/smoked ready-to-eat fish" lists a temperature of (b)(4) or less at the "cooling" critical control point to control pathogen growth during cooling, but does not list the time that it takes to cool the product to (b)(4) or lower.

4) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR § 110, to comply with 21 CFR § 123.11(b). However, on October 22, 2009, your firm did not monitor the condition and cleanliness of food contact surfaces with sufficient frequency to ensure compliance as evidenced by:

• The food residues observed on food contact surfaces after cleaning and sanitizing operations on the (b)(4) slicing machine and the (b)(4)fish skinner;

• The food residues observed on a protective apron hanging from a wall in the Southwest comer of the cutting/cleaning room; and,

• An unidentified black colored material within eight inches of the end of the water supply hoses hanging from the ceiling of the cutting/cleaning and rinsing/hanging rooms, and the brining refrigerator (these hoses are fed into large plastic totes that hold seafood products during cleaning, brining, and rinsing steps of the manufacturing process where they remain for extended periods of time).

5) Building, fixtures, and other physical facilities of the plant shall be maintained in sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated in order to comply with 21 CFR 110.35(a). However, FDA investigators observed the following non-food-contact surfaces in disrepair and/or not easily cleanable:

• A section of white paneling along the Southern wall of the cutting/cleaning room, on the West side of the refrigerator door, was partially detached from the wall at the floor junction;

• The metal door guide bracket on the North side of the brining refrigerator door in the rinsing/hanging room was observed to be loose and sitting in standing water;

• The fans located in the drying room had an accumulation of filth on the protective shields; these fans were positioned so that the air flow is directed at seafood products to facilitate drying;

• In the brining refrigerator, several of the dividing brackets of the ceiling tiles were in disrepair and had an unidentified green and black colored growth on the surface of the brackets (these brackets were directly above in-process seafood); and

• Then was an accumulation of water beneath the floor tiles in the smoke oven room located within two feet of the smoke oven closest to the packing room (when sufficient weight was placed on the tiles water squirted through the gaps in the tile onto the smoke oven room floor).

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 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. Please send your reply to the Food and Drug Administration, Attention: Dean R. Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, New York 14202.

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 operating. If you have questions regarding any issue in this letter, please contact Mr. Rugnetta at (716) 541-0324.