| Public Health Service Food and Drug Administration |
Central Region 10 Waterview Blvd,. 3rd Floor Parsippany, NJ 07054 |
Department of Health and Human Services
August 08, 2011
WARNING LETTER
United Parcel Service
Mr. William Melloy
Chief Financial Officer/Co-President/Co-Owner
Porky Products Inc,
400 Port Carteret Drive
Carteret, NJ 07008-3526
11-NWJ-22
Dear Mr. Melloy,
The Food and Drug Administration inspected your seafood processing and importer establishment, located at 400 Port Carteret Drive, Carteret, NJ on 04/28/2011 through 05/17/2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 Part 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 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). Your firm was found to be importing fish and fishery products from Canada. And while your firm responded that you will import products only from those firms on the "List of Canadian Establishments Approved for Export" that is monit.ored by the Canadian Food Inspection Agency (CFIA), it is your firm's responsibility to ensure that you fulfill the special requirements for imported products, in compliance with 21 CFR 123.12 for all your products and that your firm maintain records demonstrating your compliance. Although the firms are listed on the CFIA approved list, your firm should maintain copies of that list demonstrating that, at the time of importation, the firm was listed as approved by CFIA.
Accordingly, your Salted Smoked Split Herring, Vacuum Packed Back-Split Salted Mackerel, Salt Mackerel Fillets in Brine, and Pickled Back-Split Mackerel 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 Hazard & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and 123.6(b). However, your firm does not have a HACCP plan for Vacuum Packed Back-Split Salted Mackerel in plastic bags, to control the food safety hazards of histamine (scombrotoxin) and pathogen growth and toxin formation. Please be advised that in compliance with 21 CFR 123.6(b) (2), your firm may group this product with your existing plan if, when conducting your hazard analysis for this product, your firm determines that the hazards, critical control points, critical limits, etc. are identical to those in your existing plan.
2. You must conduct or have conducted 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 123.6(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 Smoked/Salted Mackerel products covering seafood products such as, Salt Mackerel Fillets in Brine and Pickled Back-Split Mackerel, does not list the food safety hazards of histamine (scombrotoxin) and pathogen growth and toxin formation.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, 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 seafood HACCP plan for Smoked/Salted products, lists a critical limit of"must receive product at 40 degress or less," at the Receiving critical control point which is not adequate to control histamine (scombrotoxin) formation and pathogen growth and toxin formation. Transportation times to your facility exceed 4 hours. When refrigerated products that are associated with the food safety hazard of pathogen growth and toxin formation are in transit for an extended period of time (e.g. longer than 4 hours), FDA recommends either requiring time/temperature data logs from the transporter or monitoring the adequacy of cooling media (e.g. ice). Prevention of the hazard of histamine (scombrotoxin) formation requires similar controls. Monitoring internal temperatures or product temperatures is not sufficient to address fluctuations of temperature during transport.
We note that your firm uses high temperature alarms with continuous monitoring devices on your coolers. However, reference to these devices is not included in your plan. Your firm needs to amend your HACCP plan to include reference to the use of the continuous monitoring and recording devices at the "Storage" critical control point. Your firm should also include a daily check of the monitoring records and of the equipment. You should also include appropriate corresponding corrective actions in your corrective action plans, to prevent distribution of potentially unsafe products and to correct the causes of the deviations.
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 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and /or enjoin 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 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) 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 for your fish or fishery products, including those that you import into the United States.
Please send your reply to: Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054, Attention: Stephanie Durso, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Ms. Durso at 1-973-331-4911.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
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