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WARNING LETTER

Kerry Inc. MARCS-CMS 577100 —

Product:
Food & Beverages
Seafood/Seafood Product

Recipient:
Recipient Name
Mr. Gregory T. Irby
Recipient Title
Plant Manager
Kerry Inc.

7401 Will Rogers Blvd.
Fort Worth, TX 76140
United States

Issuing Office:

United States


April 2, 2019

CMS Case # 577100

WARNING LETTER

UPS Overnight

Mr. Gregory T. Irby, Plant Manager
Kerry, Inc.
7401 Will Rogers Blvd.
Fort Worth, TX 76140

Dear Mr. Irby,

From February 11, 2019 through February 21, 2019, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 7401 Will Rogers Blvd, Fort Worth, TX 76140. 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). Accordingly, your seafood soups 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.

During our inspection of your facility, our Investigator’s observations were noted on a Form FDA 483, Inspectional Observations, issued to you on February 21, 2019. We acknowledge your firm’s response to the observations dated, March 13, 2019. We believe that your response to the observations listed on the Form FDA 483 are adequate; however, after further review of your firm’s HACCP plan and manufacturing processes, additional violations were noted.

Your significant violations are as follows:

1. You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6 (a) 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.”

Your firm’s HACCP plan for “Seafood Soup and Sauces” does not list two critical control points for hot filling and container sealing operations to control introduction of pathogenic bacteria after the cooking process. Recontamination between cooking and reduced oxygen packaging in a continuous filling system, where the product is packaged directly from the kettle, can be controlled by hot filling at or above (b)(4). Your firm does not monitor the fill temperature using a continuous temperature measuring instrument during the hot filling process, therefore you cannot ensure that the product temperature is (b)(4) or higher as the product enters the final container. Additionally, poorly formed or defective container closures can increase the risk of pathogens entering the container through container handling that occurs after the cooked product is filled into the reduced oxygen package. Container closure can be controlled by adherence to seal guidelines that are provided by the container or sealing machine manufacturer and periodic seal inspection. Your firm does not perform any actions to ensure the container closures are not defective.

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4).

Your firm’s HACCP plan for “Seafood Soup and Sauces” lists a monitoring procedure at the Cooking CCP that is not adequate to control pathogenic survival through the cooking process. Specifically, your monitoring procedures for the Cooking CCP states that “(b)(4) of product in cooking kettle” will be monitored at a frequency of “(b)(4)”. The guide states that in the absence of the EPIPT (End-Point Internal Product Temperature), established by a scientific study, the cooking temperature and time must be monitored continuously, with a visual check of the recorded data at least (b)(4).

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.

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 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.

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 Modernized Good Manufacturing Practice regulation (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Section 743 of the Act, [21 USC 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 USC 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.

Your written response should be sent to Casey L. Hamblin, Recall Coordinator/Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions regarding the content of this letter, please contact Mrs. Hamblin at 214-253-5222 or Casey.Hamblin@fda.hhs.gov.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director