Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575009.htm
Timestamp: 2019-01-22 10:05:52
Document Index: 524518694

Matched Legal Cases: ['§ 360', '§ 351', 'art 225', '§ 351', '§ 379', '§ 379']

Burkmann Industries Inc. 8/29/17
Warning letter 53330
Thomas L. Hastings, Vice President
Burkmann Nutrition Inc.
1111 Perryville Rd.
The U.S. Food and Drug Administration (FDA) conducted an inspection of your feed facility located at 1111 Perryville Road, Danville, KY on June 2, June 6, and June 27, 2017. This inspection was conducted in response to a Reportable Food Registry (RFR) event regarding the death of at least 23 cattle after consuming your product, 2858 - WCN Balancer R1400 TZI, which contained elevated levels of Monensin. This event was reported to FDA on May 30, 2017. This letter notifies you that as a result of the evidence collected during the investigation, including facility inspection and samples collected by FDA, we found serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and it’s implementing regulations. You can find FDA regulations and the FD&C Act through links on FDA’s home page at http://www.fda.gov.
FDA found that you have manufactured and distributed a medicated animal food, which contained a superpotent concentration of Monensin in violation of the FD&C Act. On May 8, 2017, you manufactured 2858 - WCN Balancer R1400 TZI, lot 205087-3 containing the animal drug Monensin. Results from a sample obtained by FDA for this lot of cattle food found levels of Monensin at 9070 grams per ton (10,000 mg/kg or ppm), which was 648% of the labeled concentration. Monensin is approved for use in medicated Type B cattle foods for growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers) for increased rate of weight gain with mixing instructions to yield a Type C cattle food with a concentration of 15 to 400 g to be fed at a rate of 20 to 200 mg/head/day. The Type B medicated cattle food 2858 - WCN Balancer R1400 TZI is labeled to be further mixed at a rate of 4 ounces into a pound or more of grain or roughage to supply a concentration of 175 mg of Monensin/head/day. However, because this lot was superpotent, following the labeled mixing instructions would yield a concentration of ~ 1134 mg of Monensin/head/day. The superpotent 2858 - WCN Balancer R1400 TZI, lot 205087-3 was fed to cattle resulting in the death of at least 23 at the time of the inspection. Because 2858 - WCN Balancer R1400 TZI containing the drug Monensin was superpotent and not in conformance with the approval, your medicated cattle food is unsafe under section 512(a)(2)(A)(i) of the Act [21 U.S.C. § 360B(a)(2)(A)(i)], and adulterated under section 501(a)(6) of the Act [21 U.S.C. § 351(a)(6)].
Furthermore, the inspection 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]. Because of these CGMP deviations, the medicated animal food manufactured, processed, packed, or held at your facility is adulterated under Section 501(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)].
These CGMPs require that “Adequate procedures shall be established and used for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and nonmedicated feeds” (21 CFR 225.165).
Your firm’s written procedures entitled, “Amended Procedures for 2510-2728-711”, states:
The procedures listed below are to be used in addition to standard operating and sequencing procedures for 2510 (Rumensin Mixing Concentrate)***
The inspection revealed that you failed to follow both of these steps of your procedures following the production of the Monensin concentrate, 2510-Rumensin Mixing Concentrate-30, lot 205087-2, which contributed to the adulteration of the subsequent manufactured animal food product, 2858 - WCN Balancer R1400 TZI lot 205087-3. While you have established procedures to avoid the unsafe contamination of medicated and nonmedicated feeds, the failure to use these procedures is a violation of 21 CFR 225.165.
This deviation from CGMP regulations for non-licensed medicated animal food manufacturers is a repeat deviation, which your firm has been cited for during inspections that occurred November/December 2014 and August/September 2015. As a result of the November/December 2014 inspection, FDA sent you an untitled letter dated June 2, 2015.
FDA acknowledges your firm has made some changes and corrections in response to Agency findings and discussions during the previous inspections. Furthermore, FDA acknowledges your response to the FDA483 (Inspectional Observations) regarding the most recent inspection. We acknowledge that you have taken responsibility for the incident and recalled the identified product, promised to discontinue production of the concentrated formulations, addressed personnel issues, and intend to compensate for the loss of cattle. However, we do not find your promised corrections sufficient to ensure that your firm's manufacturing processes and controls conforms to the CGMP requirements in 21 CFR 225. Specifically, your response does not provide any new or updated operating procedures or control steps in your manufacturing operations, or any information on how you intend to verify manufacturing steps are conducted according to your written procedures to ensure that there is no unsafe drug carryover between production runs.
Please be advised that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. You are responsible for ensuring that your facility operates in compliance with the FD&C Act and all applicable regulations. The specific violation(s) noted in this letter are symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. To avoid manufacturing and distributing adulterated products, it is essential that your firm have a system in place to ensure the safety of your manufactured animal food. It is your responsibility to ensure that your overall procedures and systems adequately prevent adulteration so that you are not manufacturing and distributing an adulterated product. You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
Please note that beginning in September 2017, your facility will be subject to the CGMPs for food for animals (21 CFR 507, subpart B). Animal food that is not manufactured, processed, packed, and held according to CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii)).These CGMP requirements apply to both medicated and nonmedicated animal food. Some items to remember as you bring your facility into compliance:
Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the contamination of animal food (21 CFR 507.25(c)(4)).
In addition to compliance with the CGMPs, in the future you must also comply with hazard analysis and risk-based preventive controls requirements (21 CFR 507, subpart C and E), unless an exemption applies (21 CFR 507.5). According to these subparts, 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.
Section 743 of the FD&C 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 FD&C 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, 21 U.S.C. § 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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. You should include in your response any documentation, including photographs, of the corrections you have taken or other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time or you cannot complete all corrections within fifteen (15) working days, please state the reason for the delay and include a timetable for implementation of those corrections.
Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Allison Hunter at 513-679-2700 x 2134.