Farmers Ranchers Coop Assn - 559583 - 10/05/2018

WARNING LETTER

October 5, 2018

Via United Parcel Service

Signature Required

CMS # 559583

Cindie Kesler, CEO/President

Farmers/Ranchers Cooperative Association of Ainsworth

224 S Main Street

Ainsworth, NE 69210

Dear Ms. Kesler,

FDA conducted an inspection on May 21 and 22, 2018 of your non-licensed medicated animal food facility located at 224 S, Main Street, Ainsworth, NE. During this inspection FDA documented significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal food manufacturers, Title 21 Code of Federal Regulations (CFR), Part 225 [21 CFR 225]. These CGMPs deviations cause your non-medicated and medicated animal food to be adulterated under 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. 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.

In addition, on two occasions you manufactured and distributed animal food that was intended to be non-medicated but was determined to contain animal drugs by the Nebraska Department of Agriculture’s (NDA) surveillance sampling. Specifically:

1. NDA sampled and analyzed your “Sandhills Select Horse Feed G00005-00” lot code #10/02/2017 and found monensin at 4.2 parts per million or 4 grams/ton. Monensin is not approved in horse food and can cause serious adverse health consequences or death to horses if consumed.

2. NDA sampled and analyzed your “(b)(4)” lot code #11/22/2017 and found chlortetracycline at 57 grams/ton. Although chlortetracycline is approved for use in swine food, your “(b)(4)” is not labeled to contain any animal drugs.

Adulterated Animal Food - Medicated Feed CGMP Violations

FDA’s inspection in May 2018 documented significant deviations of the CGMP regulations for non-licensed medicated animal food manufacturers (21 CFR Part 225). We acknowledge your written response dated June 5, 2018; however, your response does not adequately address the deviations, as discussed below.

1. You failed to adequately investigate and implement corrective actions when laboratory assays of drug components indicated that medicated feed was not in accordance with permissible limits, and to retain such records on the premises for one year as required by 21 CFR. 225.158. You were notified by NDA that your “Sandhills Select Horse Feed”, lot code #10/02/2017, was contaminated with monensin, and you were notified by your customer, (b)(4) that your “(b)(4)” lot code #11/22/2017 was contaminated with Chlortetracycline, this caused these non-medicated animal foods to not be in accordance with the permissible limits. During our inspection no records were provided of an investigation or corrective actions regarding this incident.

Your June 5, 2018 written response discusses your corrective actions for the Sandhills Select Horse feed and the (b)(4) non-medicated animal foods which NDA sampled and found to contain new animal drugs. Your response stated that you sent retained samples for analysis, updated the sequencing chart, and trained employees on the sequencing chart. However, this is not adequate because your response does not indicate you have investigated the cause of these two lab results. These results could have a variety of causes from situations other than carryover due to improper sequencing. For example, carryover may occur because no flush was implemented, or an ineffective flush occurred. In addition, the presence of drugs in a non-medicated feed may result from an operator or machine error that resulted in the drug being inadvertently added to a non-medicated batch. Your corrective actions do not identify the root cause of the incidents and do not address the other possible ways the incidents could have occurred.

2. You failed to establish and maintain adequate procedures for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality and purity of these drug sources as required by 21 CFR 225.142. During our inspection, we found multiple Type A medicated articles or Type B medicated feeds, used to further manufacture animal food, which were not accounted for in your inventory. For example, the following new animal drugs were not recorded in your drug inventory:

a. (b)(4) (monensin) Lot# (b)(4) – (b)(4) bags (55.1 lbs)

b. (b)(4) % Type B medicated feed - (b)(4) bags

c. (b)(4) % (Fenbendazole) Lot# (b)(4) Type B medicated feed - (b)(4) bags

d. (b)(4) (Ractopamine HCL) Lot# (b)(4) Type A medicated article - (b)(4) bags (25 lbs)

e. (b)(4) % (Fenbendazole) Lot# (b)(4) Type B medicated feed - (b)(4) bags

Your June 5, 2018 written response states that you have implemented SOPs and conducted additional training to ensure all new animal drugs are included on your drug records. You included the SOP signed by your employees. We will evaluate these changes and the effectiveness of your SOP and training at our next inspection.

Conclusion

The above is not intended as 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.

In addition to the incidents listed above, in June 2018 your firm bagged urea into unmarked bags intended for internal use, which your employee mistakenly distributed as mono-calcium phosphate. This product was subsequently fed to your customer’s cattle and resulted in the death of four cows and illness of two cows. We acknowledge that upon notification from your customer, you promptly recalled this product and submitted a Reportable Food Registry (RFR) report. However, this incident further indicates a continued lack of control over implementing CGMPs in your facility.

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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

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 FD&C Act and are manufacturing, processing, packing, or holding medicated feed under 21 CFR part 225 are also subject to the Current Good Manufacturing Practice (CGMP) requirements in 21 CFR part 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 FD&C Act). 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 part 507, subparts C and E, unless an exemption applies (21 CFR 507.5). To comply with the preventive controls 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 hazardsfor each type of animal food produced at your facility. The PCQI, or designee, must then evaluate the known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control, and you must implement preventive controls as appropriate to your animal food and facility. Please see our draft guidance: Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.

You should respond in writing within fifteen (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 fifteen (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 Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Mr. Hutchison at 913-495-5154.

Sincerely,

/S/

Cheryl A. Bigham

Program Division Director

Office of Human and Animal Foods Division II West