Inspections, Compliance, Enforcement, and Criminal Investigations
P East Trading Corporation
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Ave.
Jamaica, NY 11433
October 23 , 2008
VIA FED EX
P East Trading Corporation
327 Longfellow Avenue
Bronx, New York 10474-7104
REF: NYK 2009-02
Dear Mr. Pae:
We inspected your seafood processing and importer establishment, located at 327 Longfellow Avenue, Bronx, New York 10474-7104 on July 1 & 9, 2008. 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 this part, 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 refrigerated salted mackerel fillets and smoked herring fillets 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 conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 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 refrigerated salted mackerel and smoked herring fillets does not list the food safety hazard of pathogen growth and toxin formation, including that of Clostridium botulinum, at the "receiving" and "storage" critical control points.
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 refrigerated salted mackerel and smoked herring lists monitoring procedures at the "receiving" and "storage" CCPs that are not adequate to control the hazard of scombrotoxin formation. Specifically, your HACCP Plan lists monitoring procedures that reference only the taking of product temperatures upon receipt,for the "receiving" CCP and (b)(4) for the "storage" CCP. When refrigeration is a necessary safety control and products are held for a significant period of time where unsafe temperature fluctuations may occur and lead to time and temperature abuse of the products, FDA recommends implementing a monitoring procedure that shows safe conditions have been continuously maintained. For example, FDA recommends that your plan include procedures at receiving that ensure that safe transportation conditions have been maintained throughout transit to your firm, such as continuous time/temperature data records. FDA also recommends that you implement similar controls during your cooler storage periods. Time/temperature data loggers are examples of acceptable methods of monitoring refrigerated holding conditions when products are not stored under ice.
3. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a).
Your written verification procedures for your importation of fish and fishery products from (b)(4) state that you will obtain a copy of the suppliers' HACCP plan as well as a written letter of guarantee; however, you do not have HACCP plans from any of your (b)(4) suppliers. Therefore, you did not implement your written affirmative step procedures because you did not maintain on file a copy of the foreign processor's HACCP plan and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with HACCP requirements. You informed FDA's investigator that you would change your written affirmative step to comply with verification requirements by other means. You should provide documentation that you have made this change to your written affirmative step process and that you are implementing this affirmative step.
Further, FDA notes that in accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 801(a)(3) of the Act, 21 U.S.C. § 381(a)(3).
We may take further action if you do not promptly correct these violations. For instance, we may take. further action to refuse admission of your imported fish or fishery. products under Section 8Q1(a) of the. Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seizing your product(s) and/or enjoining your firm from further violating the Act.
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 importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for the fish or fishery products that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have questions regarding any issues in this letter, please contact Lillian Aveta at 718-662-5576.
Otto D. Vitillo