Inspections, Compliance, Enforcement, and Criminal Investigations
JBS USA Holdings dba JBS Distributing 3/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
March 6, 2012
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Donald Jackson, Chief Executive Officer
JBS USA Holdings, Inc.
1770 Promontory Circle
Greeley, CO 80634
Dear Mr. Jackson:
We inspected your seafood processing facility, Pilgrim’s Distributing, located at 3420 Avenue F, Arlington, Texas, on November 3 – 7, 2011. Processing of fish or fishery products includes the handling, storing, preparing, heading, and eviscerating as defined in 21 CFR 123.3(k)(1). We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, Title 21, Code of Federal Regulations, (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 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 Ready-To-Eat Tuna Salad is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
As of the date of this letter we have not received a response from your firm to FDA-483 violations noted during our inspection.
Your significant violation is 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 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 (b). However, your firm does not have a HACCP plan for your Tuna Salad to control the food safety hazard of C. botulinum and pathogenic bacteria growth and toxin formation.
In addition, in accordance with 21 CFR 123.10, at a minimum an individual at your firm must complete training in applications 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 may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
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)). 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.
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 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance Officer at 4040 North Central Expressway Ste 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact Ronda Loyd-Jonesat 214-253-5242.
Reynaldo R. Rodriguez, Jr.
Jeffery Knute Klingen, General Manager
3420 Avenue F, Arlington, Texas 76011