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WARNING LETTER

JBS Souderton, Inc. dba MOPAC MARCS-CMS 574386 — 23/04/2019

JBS Souderton, Inc. dba MOPAC - 574386 - 04/23/2019

Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
Mr. Andre Nogueira
Recipient Title
President & CEO
JBS Souderton, Inc. dba MOPAC

1770 Promontory Circle
Greeley, CO 80634
United States

Issuing Office:
Division of Human and Animal Food Operations East II (HAFE2)

6000 Metro Drive, Suite 101, , MD 21215
Baltimore, MD 21215
United States

Via UPS

VIA UPS Tracking Number:

1Z19W9A01395486096

 

 

Tuesday, April 23rd, 2019

 

JBS USA Holdings, Inc.

Mr. Andre Nogueira, President & CEO

1770 Promontory Circle

Greeley, Colorado  80634

 

WARNING LETTER

CMS: 574386

 

Dear Mr. Nogueira:

 

On March 13th and 14th, March 19th, March 30th, August 6th, and October 17th, 2018, the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your rendering plant, JBS Souderton, Inc dba MOPAC, located at 741 Souder Road, Souderton, Pennsylvania, 18964.  The inspection was a joint effort with the Pennsylvania Department of Agriculture (PDA), which inspected your plant on several days between March 13th and June 6th, 2018.  Your rendering plant produces animal food ingredients distributed to animal food manufacturers.  This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection of your operation and listed in the Form FDA 483 issued to you at the conclusion of the inspection. 

 

Our inspection found you violated FDA’s Current Good Manufacturing Practice (CGMP) requirements for animal food, which causes your products to be adulterated.[1]  In addition, the presence of pentobarbital in your animal fat products, including pure tallow, “(b)(4) Tallow”, and “(b)(4) Tallow”, causes these products to be adulterated because the animal food contains an unsafe new animal drug. [2]  The drug is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance established for the presence of pentobarbital in the edible tissues of animals.[3] 

 

It is a prohibited act to introduce or deliver for introduction into interstate commerce any food that is adulterated or misbranded.[4]

 

You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov. Animal food CGMP requirements are in 21 CFR part 507, subpart B, with related requirements in 21 CFR 507.4 and 21 CFR part 507, subpart F. In addition, guidance on the animal food CGMP requirements can be found in CVM GFI # 235 Current Good Manufacturing Practice Requirements for Food for Animals, available at  https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforc….

 

Adulteration Due to Animal Food Current Good Manufacturing Practice (CGMP) Violations

 

Your firm failed to examine raw materials and other ingredients to ensure that they are suitable for manufacturing and processing into animal food (21 CFR 507.25(b)(1)).

 

Specifically, our investigation found that you failed to identify and exclude raw materials and ingredients containing pentobarbital.  For example, your firm did not conduct testing on raw materials other than grease.  In March, during the investigation, you indicated you implemented several changes to attempt to gain more information about your suppliers and control over your incoming ingredients.  These actions included refusing to receive equine ingredients, having your suppliers complete a questionnaire about their food safety practices, having suppliers sign guarantees that they do not pick up euthanized animals, and excluding suppliers that could not meet these new requirements.   You stated you also performed a comprehensive cleaning of your equipment.  On May 30, 2018, you wrote to us reiterating these actions and stating that you will no longer distribute tallow for animal food unless it is “produced in a clean tank as confirmed by testing showing that the initial material from the tank tests negative for pentobarbital.” You also stated in the same correspondence that “[a]t the conclusion of the clean out process, when all tanks have been determined to be clean, we will test our tallow randomly to ensure that our enhanced protocols remain effective.”

 

However, a sample collected by FDA in August 2018 from a tank that was filled after these corrective actions were taken was found to be contaminated with trace levels of pentobarbital.  This indicates that the changes you have made to your examination of raw materials and other ingredients from your suppliers may not be sufficient to prevent pentobarbital contaminated ingredients, such as those potentially sourced from euthanized animals, from entering your facility and contaminating your finished tallow product.

 

 

Adulteration Due to the Presence of Pentobarbital

Pentobarbital sodium is a drug approved for anesthetizing certain animals.  There is no established tolerance for the residues of pentobarbital in animal tissues.  Therefore, when used in food-producing animals, it can render the tissues of those animals adulterated.

 

FDA analysis of your animal fat products, including pure tallow, (b)(4) Tallow”, and “(b)(4) Tallow”, revealed that some of the products were contaminated with pentobarbital. 

 

On March 19, 2018, FDA took nine samples of animal food from retention samples collected at your facility.  Four of these samples tested positive for pentobarbital using qualitative methods.  Three of these samples from tallow shipped to (b)(4) were further analyzed using quantitative methods and had levels of pentobarbital ranging from 61.8 +/- 19 to 277 +/-70 ng/g. 

 

On August 6, 2018, FDA took six sub-samples from different tanks located at your facility.  These tanks were all filled on or after July 25, 2018.  One sub-sample contained trace levels of pentobarbital.  A trace level indicates that the level of pentobarbital was above the 4.0 ng/g limit of detection, but below the 10.0 ng/g level of quantification.  

 

This presence of pentobarbital causes your animal food to be adulterated[5] because the food contains a new animal drug that is unsafe[6] because it was not used in conformance with the drug approval, which does not have a tolerance for pentobarbital residue in the edible tissue of animals.

 

It should be noted that from February 23, 2018 to June 6, 2018, the PDA also collected and analyzed a variety of your animal food products at your facility and at your customers’ facilities.  Their analyses of these samples indicated levels of pentobarbital ranging up to 680 ppb (ng/g).   

 

Corrective Actions

Our investigation revealed that you continued to distribute adulterated products after you received formal notification of pentobarbital contamination from your customer on February 13, 2018, and after formal notification of positive pentobarbital samples from the Pennsylvania Department of Agriculture on or about April 5, 2018. 

 

You stated that your firm performed cleaning to remove the pentobarbital contaminated animal food from your equipment.  On April 17, 2018, you informed FDA that you had completed cleaning of your equipment, including conveyances, conduits, cookers, centrifuges, and some of the storage tanks that received that tallow.  You stated you would continue until all storage tanks were cleaned.  In a May 30, 2018 correspondence you reiterated that you would continue to clean all storage tanks and expected that this process would be complete within 30 days.     

 

Also in your May 30, 2018 correspondence, you stated that in response to three tallow samples sold to the chemical industry that tested positive for pentobarbital, you identified and visited with all of your suppliers that may present a risk for entry of euthanized animals into your rendering stream.  You obtained a guarantee from each supplier that they will not provide euthanized animals.  As discussed during the inspection, you had previously visited and stopped using some suppliers that you considered at risk of providing pentobarbital contaminated ingredients.  You indicated you would continue randomly testing your tallow product to ensure it is not contaminated.       

 

Despite these corrective actions, an FDA sample taken from one of your tanks that was filled on July 27, 2018, after your cleaning and supplier corrective actions were complete showed trace amounts of pentobarbital.  It is not clear whether these trace amounts occurred due to insufficient cleaning, or whether the tank was contaminated by an incoming raw ingredient containing pentobarbital.

 

On August 8, 2018, FDA inquired whether you planned to recall, put a hold on distributing, or send notification to all customers regarding the animal food product contaminated with pentobarbital, regardless of the customer’s business.  You stated you did not plan to do so, but had made an offer to animal food producing customers that received animal food product to remove any product deemed positive for pentobarbital and to have their tank cleaned. For customers that accepted your offer, you stated that you removed the material(s) and cleaned their tank(s).  We acknowledge this action but it is important to remove all adulterated animal food from the marketplace regardless of the customer’s business because they may have used or distributed it for an animal food use. 

 

On November 26, 2018, you wrote to FDA, describing your withdrawals and attempted withdrawals of pentobarbital contaminated product from your customers. We are unable to assess your corrective action because you have not implemented a voluntary recall or otherwise provided documentation demonstrating all contaminated products were removed from the marketplace. It is your responsibility to recall or otherwise provide assurance that the product is not further distributed in the marketplace.

 

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility.  You are responsible for investigation and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  As a producer of animal food products, you are responsible for ensuring that your firm complies all requirements of federal law and FDA regulations.

 

You should take prompt action to correct the violations described in this letter and establish and implement procedures to ensure that these violations do not recur.  Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

 

We also have the following comments:

 

1.  Regarding 21 CFR 507.25(b)(1), an examination of raw materials or other ingredients relevant to your operations may include: (1) reviewing specifications, guarantees, or other associated information that your firm receives; (2) performing a visual check of the animal food; and/or (3) performing relevant sampling and testing.

 

2.  You also stated that you would routinely sample and test to ensure that your new processes are adequate.  Management of an establishment must ensure that chemical testing procedures are used where necessary to identify possible animal food contamination (see 21 CFR 507.25(a)(6)). 

 

3.  Your firm is registered with FDA in compliance with section 415 of the Act.  Therefore, you are subject to the hazard analysis and risk-based preventive controls requirements in 21 CFR part 507, subparts C and E, unless an exemption applies (21 CFR 507.5). According to these requirements, you must develop and implement a food safety plan.  Specifically, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards associated with your animal food.  The PCQI, or designee, must evaluate the hazards to determine whether your firm has any hazards requiring a preventive control, to significantly minimize or prevent the hazard.  Please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/UCM592870.pdf. FDA will confirm your compliance with the Preventive Controls for Animal Food regulation during future inspections.     

 

Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Your response should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

 

Your written response should be sent to Evelyn Bonnin, Program Division Director/District Director, United States Food & Drug Administration, Human & Animal Food Division II East, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215.  If you have any questions, please contact Jessica D. Weber, Compliance Officer, at the above physical address, by phone at (410) 779-5407, or by email at jessica.weber@fda.hhs.gov.

 

 

 

Sincerely,

/S/

Evelyn Bonnin

Program Division Director

District Director

Human & Animal Food Division II East

Baltimore District Office

 

 

 

Cc:      

JBS Souderton, Inc. dba MOPAC

Mr. Todd Scherbing, General Manager

741 Souder Road

Post Office Box 64395

Souderton, Pennsylvania 18964

 

Pennsylvania Department of Agriculture

            Bureau of Plant Industry

            Dr. Ruth A. Welliver, Director

            2301 N. Cameron Street

            Harrisburg, Pennsylvania 17110

 

 

[1] See section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

[2] See section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)]

[3] See section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)]

[4] See section 301(a) of the Act [21 U.S.C. 331(a)]

[5] See section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)]

[6] See section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)]