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WARNING LETTER

Gilman Cooperative Creamery Association MARCS-CMS 563944 —

Product:
Animal & Veterinary
Animal Feed

Recipient:
Recipient Name
Adam L. Bonovsky
Recipient Title
Manager
Gilman Cooperative Creamery Association
Gilman Cooperative Creamery Association

9920 115th Street NE
P.O. Box 7
Gilman, MN 56333
United States

Issuing Office:
Minneapolis District Office

United States


October 5, 2018


WARNING LETTER


Via UPS Overnight Delivery                                                        Refer to CMS 563944


Adam L. Bonovsky
Manager
Gilman Cooperative Creamery Association
9920 115th Street NE, P.O. Box 7
Gilman, Minnesota  56333

Dear Mr. Bonovsky:

The U.S. Food and Drug Administration (FDA) and the Minnesota Department of Agriculture (MDA) conducted an inspection of your commercial feed mill located at 9920 115th Street NE, Gilman, Minnesota, on July 5, 10, and 24, 2018.  This inspection was conducted in response to a Livestock Food Registry (LFR) event, received by FDA on  July 2, 2018, which reported the death of five horses after consuming your custom Horse Blend 985 manufactured on June 4, 2018.  FDA found through laboratory analysis that your custom Horse Blend 985 contained monensin.  Monensin is not approved in horse food and can cause serious adverse health consequences or death to horses if consumed. 

The presence of monensin in your Horse Blend 985 causes it to be unsafe because the animal food containing the new animal drug was not used in conformance with the drug approval as outlined in section 512(a)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360b(a)(2)(A)(i).  As a result, the animal food containing the new animal drug is adulterated as outlined in section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).  In addition, our inspection revealed violations of the Current Good Manufacturing Practice (CGMP) requirements for medicated feed, which cause your non-medicated and medicated animal food to be adulterated as outlined in section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), and section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B), respectively.

Medicated feed CGMP requirements are in Title 21, Code of Federal Regulations, Part 225 (21 CFR 225).  You may find the Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.

Adulterated Animal Food

During our July 2018 inspection we collected a sample of your non-medicated custom Horse Blend 985, manufactured on June 4, 2018, for drug analysis.  The sample analysis found 143 parts per million (ppm) of monensin in your product.  Monensin is not approved for use in horse food and can cause serious adverse health consequences or death to horses if consumed. Specifically, horses may experience health consequence such as tachycardia, ataxia, or gross lesions in cardiac and skeletal muscles after consuming monensin.  As a result, the new animal drug approval for monensin requires the following caution statement to be placed on all formulations containing monensin:  “Do not allow horses or other equines access to feed containing monensin.  Ingestion of monensin by horses has been fatal,” 21 CFR 558.355(d)(6).  Therefore, this animal feed containing a new animal drug is unsafe and adulterated because the animal feed and its labeling, distribution, holding, and use does not conform to the approved new animal drug application.[1]

Medicated Feed CGMP Violations

The violations of the medicated feed CGMP regulations for non-licensed medicated animal food manufacturers (21 CFR 225.120-220) observed during the inspection include, but are not limited to, the following:
 
  1. You failed to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds, 21 CFR 225.165. 

Your batching and mixing operations are inadequate to ensure that your medicated feed does not contaminate other medicated and non-medicated feeds.  On June 4, 2018, you manufactured a custom cattle mix containing (b)(4) (monensin).  After the manufacture of this medicated feed, it does not appear steps were taken to either flush or clean equipment.  The two batches immediately following, a medicated bambermycin custom steer mix and a non-medicated custom Horse Blend 985, were both found to contain monensin.  Your facility notes on the batching records the following procedure:  “(b)(4) flush is required for all medicated feed.”  You failed to document that a flush occurred per your procedure.  As a result, your facility cannot ensure your flushing procedure was followed after manufacture of a medicated feed.  This is a repeat violation from the previous inspection where it was noted that your firm is not documenting on the production record when a flush occurs.

Additionally, it was noted during this inspection that there is excessive build-up on your horizontal mixer, specifically, inside the drum, on the horizontal ribbon within the drum, on the horizontal ribbon in front of the drum, and on the exit chute to the conveyor belt.  Also, it was noted that you did not have a regular cleaning schedule established for the maintenance of this equipment.  Excessive build-up and lack of cleaning may contribute to the carry-over of drugs from one batch to another because build-up containing new animal drugs on equipment can dislodge during manufacturing of subsequent batches and contaminate the batch with the new animal drug. 
 
  1. You failed to maintain formula, production, and distribution records to identify the formulation.  Records must be maintained which identify the formulation, date of mixing, and date of shipment (if not for own use).  The records shall be adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  Such records shall be retained on the premises for one year following the date of last distribution, 21 CFR 225.202.

Your medicated feed batching records include a space to record the drug name, lot number, and pounds per batch.  During a review of your records on June 4, 2018, your production records did not have any entries for the drug name, drug lot number, and amount of drug used in the manufacture of your medicated feed.  This is a repeat violation from the previous inspection where it was noted that your firm failed to document drug lot numbers on the production record when manufacturing medicated feeds.
 
  1. You failed to identify and store bulk Type B medicated feeds in a manner such that their identity, strength, quality, and purity will be maintained, 21 CFR 225.142.

Our investigator observed several open bulk bays where Type B medicated feeds including pelleted bambermycin and lasalocid were being stored without adequate identification.

To date, the agency has not received any written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations.

Conclusion

The above is not intended to be an all-inclusive list of violations.  As a manufacturer of animal food and medicated feed, you are responsible for ensuring your overall operations and the animal food and medicated feed you manufacture and distribute are in compliance with the Act and its implementing regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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 reinspection-related costs.  A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B).  For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

(b)(3)(A)

The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) to provide a reliable mechanism to track patterns of adulteration in food to support efforts by FDA to target limited inspection resources to protect the public health.  It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.”  The responsible party is the person who submits the registration under section 415(a) of the Act, 21 U.S.C. § 350f(d), for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held.  Failure to submit a required report about a reportable food is a prohibited act under section 301(mm) of the Act, 21 U.S.C. § 331(mm).

Furthermore, your facility is now subject to the Preventive Controls for Animal Food regulations found in 21 CFR 507.  Facilities that are required to register with FDA as a food facility under section 415 of the Act and are manufacturing, processing, packing, or holding medicated feed under 21 CFR 225 are also subject to the Current Good Manufacturing Practices (CGMP) requirements in 21 CFR 507, subpart B.  These regulations provide baseline food safety and sanitation standards for facilities manufacturing, processing, packing, and holding both medicated and non-medicated animal food.  Animal food that is not manufactured, processed, packed, and held in accordance with CGMPs may be considered adulterated, 21 CFR 507.1(a)(1)(i-ii) and sections 402(a)(3) and (4) of the Act.  Animal food facilities that are subject to specific CGMPs, such as medicated feed CGMPs, must comply with those requirements as well as the requirements in 21 CFR 507, subpart B, 21 CFR 507.1(c).  For more information, please see FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at:   https://www.fda.gov/downloads/ AnimalVeterinary/GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM499200.pdf.   

In addition, you are now subject to the hazard analysis and risk-based preventive controls requirements in 21 CFR 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.  The PCQI, or designee, must evaluate identified known or reasonably foreseeable hazards to determine if 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.

You should respond in writing within 15 business days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these violations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again.  More specifically, your response should include documentation of the corrections (including how you intend to address systemic problems) your firm has taken.  If your firm’s planned corrections will occur over time, please include a timetable for implementation of those activities.  If corrections cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed.

Please send your written response to Dianna C. Sonnenburg, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Ave, Suite 600, Minneapolis, MN 55401.  If you have questions regarding any issues in this letter, please contact Mrs. Sonnenburg at (612) 758-7125.

Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations
 
[1] Section 512(a)(2)(A)(i) of the Act, 21 U.S.C. § 360b(a)(2)(A)(i), and 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii).