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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nishimaru Inc 29-Mar-05

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

Public Health Service
Food and Drug Administration

 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433


March 29, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTE
D

Mr. Takeji Nishimaru
President
Nishimaru, Inc.
76 Apollo Street
Brooklyn, NY 11222-3801

Ref. NYK-2005-09

Dear Mr. Nishimaru:

On November 23, 2004 through December 7, 2004, we inspected your seafood processing facility, located at 76 Apollo Street, Brooklyn, New York. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21; Code of Federal Regulations, Part 123, and from 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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your fresh, jack, farm-raised Time Temperature Integrator (TTI)-labeled vacuum-packed amberjack and yellowtail fillets, fresh whole farm-raised amberjack and yellowtail, and fresh mackerel are adulterated, in that they have been prepared, packed, or held under insanitay conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA's home page at www.fda.gov.

The deviations were as follows:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind offish and fishery product you process and have a HACCP plan that complies with 21 CFR 123.6. The HAACP plan must list the food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for raw farm-raised, TTI-labeled, refrigerated, vacuum-packaged yellowtail fillets and amberjack fillets does not list the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum.

Packaging conditions that reduce the amount of oxygen present in the package (e.g. vacuum-packaging) extend the shelf life of product by inhibiting the growth of aerobic spoilage bacteria. The safety concern with these products is the increased potential for the formation of C. botulinum toxin before spoilage makes the product unacceptable to consumers. In reduced-oxygen packaged products in which refrigeration is the sole barrier to outgrowth of nonproteolytic C. botulinum and the spores have not been destroyed(e.g. vacuum-packaged raw fish), FDA recommends that the temperature be maintained at 38°F (3.3°C) or below from packing to consumption. To ensure that temperature abuse does not occur during transport, FDA recommends either monitoring 1) the internal temperature of the fishery product or the ambient temperature within the carrier continuously throughout transportation or 2) the adequacy of ice or cooling medium at the time of delivery. In addition, FDA recommends that you ascertain that the TTIs are present on reduced-oxygen packaged refrigerated seafood, that they are activated and haven't changed color at the receiving critical control point.

2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind offish and fishery product you process and have and implement a written HACCP plan that complies with 21 CFR 123.6. The HAACP plan must list the critical control points to comply with 21 CFR 123.6(b) 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 histamine-forming species does not list the critical control point of receiving for controlling the food safety hazard of histamine formation. FDA recommends that secondary processors of histamine-forming fish, (processors that purchase fishery products from other processors) check every lot at receipt for the adequacy of ice or cooling medium. If a refrigerated transport is used, the secondary processor may require that transportation records documenting the time/temperature exposure of the product accompany every lot. FDA recommends that histamine-forming fish be maintained at temperatures at or below 40°F and that vacuum-packaged products be maintained at temperatures at or below 38°F when refrigeration is the only barrier to the outgrowth of Clostridium botulinum.

3. You must have and implement written verification procedures that list product specifications designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm has a product specification for vacuum-packaged amberjack fillets imported from [redacted] that does not adequately address the food safety hazard of Clostridium botulinum that is reasonably likely to be presented by the product. Your specification for vacuum-packaged amberjack should identify C. botulinum as a hazard and provide specifications for controlling the hazard.

4. You must maintain records, in English, that document the performance and results of the affirmative steps taken to implement your written verification procedures, to comply with 21 CFR123.12(c). However, your firm did not have records for the performance and results of any affirmative step for fresh whole mackerel imported from [redacted]

5. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring frequency of visual check for ice every [redacted] as listed in your HACCP plan for farm-raised, TTI-labeled, refrigerated, vacuum-packaged yellowtail and amberjack fillets to control the hazard of histamine formation. Your firm indicated to our investigator that no one checks for adequacy of ice on products in the cooler while the firm is not operating on weekends.

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.

Please 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 deviations. 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, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter may not list all the deviations 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at (718) 662-5576.

Sincerely,

/S/

Jerome G. Woyshner