Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 416798
UNITED PARCEL SERVICE
December 16, 2013
Mr. William P. Catauro, Jr.
Quality Beef Company, Inc.
25 Bath Street
Providence, RI 02908
Dear Mr. Catauro:
We inspected your seafood processing and importer establishment, located at 25 Bath Street, Providence, RI on November 8, 12, and 15, 2013. 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). 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).
Accordingly, your ready-to-eat, refrigerated seafood salad and imported, ready-to-eat, refrigerated salted smoked herring fillets areadulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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.
We have received your November 20, 2013 response to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of this inspection on November 15, 2013 and have incorporated our review of its adequacy below.
Your significant violations were as follows:
1. 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 HACCP plan, “Various Refrigerated Seafood Salad Purchased Pass-Through Products,” for ready-to-eat, refrigerated seafood salad and imported, ready-to-eat, refrigerated salted smoked herring fillets lists a critical limit, “(b)(4)” at the receiving critical control point that is not adequate to control pathogen growth and toxin formation as a result of time and temperature abuse.
In addition, our investigator observed your firm only monitors the temperature of a single unit of product for each incoming shipment your firm receives. This is inadequate to monitor the critical limit at the receiving critical control point stated in your HACCP plan.
Your firm’s November 20, 2013 response is inadequate as it did not include a revised HACCP plan for these products for review or other evidence of appropriate corrective actions.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan, “Various Refrigerated Seafood Salad Purchased Pass-Through Products,” for ready-to-eat, refrigerated seafood salad and imported, ready-to-eat, refrigerated salted smoked herring fillets lists a monitoring frequency at the “Cooler Storage” critical control point that is not adequate to control pathogen growth and toxin formation as a result of time and temperature abuse.
In addition, you must implement the monitoring procedures that you have listed in your HACCP plan, as required by with 21 CFR 123.6(b). Your HACCP plan states your firm will perform a “(b)(4)” to monitor “Ambient Cooler Temperature.” However, our investigator observed your firm does not conduct a visual observation of the calibrated cooler wall thermometer.
Your firm’s November 20, 2013 response is inadequate as it did not include information regarding the continuous monitoring temperature system referred to or other evidence of appropriate corrective actions.
3. You must have and implement written import verification, that include product specifications and an affirmative step, for ensuring that the fish and fishery products you import into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). However, your firm has no written import verification procedures and did not implement an affirmative step for ready-to-eat, refrigerated salted smoked herring fillets imported from Canada.
Your firm’s November 20, 2013 response is inadequate as it did not include evidence of implementation of these controls regarding imported fish and fishery products or other appropriate corrective actions.
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.
In addition, your firm’s HACCP plan incorrectly lists “(b)(4)” underneath the critical limit section at the receiving and refrigerated storage critical control points for ready-to-eat, refrigerated seafood salad and imported, ready-to-eat, refrigerated salted smoked herring fillets. Calibration is a verification step and records of calibration must be maintained in accordance with 21 CFR 123.8(d). Our investigator noted your firm did not maintain records of thermometer calibration. You are reminded to establish appropriate verification steps for your critical limits in the revised HACCP plan you submit in response to the Warning Letter and to implement record keeping.
Also, in accordance with 21 CFR 123.10, HACCP plan development, reassessment, modification and record review must be performed by an individual that has completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration, or who is otherwise qualified through job experience to perform these functions. Your firm does not have anyone trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions. We acknowledge your firm’s November 20, 2013 response states that personnel from your firm will attend and complete a qualified HACCP training course.
Furthermore, our investigator observed your HACCP plan, “Various Refrigerated Seafood Salad Purchased Pass-Through Products,” was not signed or dated annually, as required by 21 CFR 123.6(d). Your firm’s November 20, 2013 response did not include evidence that this has been performed.
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, 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.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Timothy M. Glod, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Glod at (781) 587-7473.
Nicholas J. Scire
Acting District Director
New England District