Inspections, Compliance, Enforcement, and Criminal Investigations
Minatare Feed Lot Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Kansas City District
11630 W. 80th Street
Lenexa, Kansas 66214
October 21, 2009
RETURN RECEIPT REQUESTED
Ref. KAN 2010-02
Charles P. Weinreis, President
Minatare Feedlot, Inc.
290151 Cattle Drive
Minatare, Nebraska 69356
Dear Mr. Weinreis:
An inspection of your licensed medicated feed mi1l10cated at 290151 Cattle Drive, Minatare, Nebraska 69356, conducted by the Food and Drug Administration (FDA) along with the Nebraska Department of Agriculture on May 13-14 and May 18,2009, documented significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225, (21 C.F.R. 225). Such deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 351 (a)(2)(B)].
Our investigation found deviations including, but not limited to, the following:
• Failure to maintain daily drug inventory records which contain the information as required by
21 C.F.R. § 225.42(b)(6). For example, some of the more than 100 daily drug inventory
records reviewed do not list the quantity of drug on hand at the beginning and end of the
work day, as required by § 225.42(b)(6)(i), the amount of each drug used, sold, or otherwise
disposed of, as required by § 225.42(b)(6)(ii), or the batches or production runs of medicated
feed in which each drug was used, as required by § 225.42(b)(6)(iii).
• Failure to maintain drug inventories of each lot or shipment of drug by means of a daily
comparison of the actual amount of drug used with the theoretical drug usage, and to
investigate any significant discrepancy and take corrective action, as required by 21 C.F.R. §
225.42(b)(7). For example, on April 20, 2009, you used (b)(4) pounds of monensin, which
is approximately (b)(4) times your normal use of such drug. You did not identify or investigate
• Failure to properly identify, store, handle and control drugs in the mixing areas to maintain
their integrity and identity, as required by § 225.42(b)(4). For example, partially used bags
of drugs such as monensin, chlortetracycline, decoquinate, and melengestrol acetate are
transferred into containers that are not labeled with the drug's lot numbers, expiration date,
and directions for use.
• Failure to maintain equipment in reasonably clean and orderly manner, as required by 21
C.F.R. § 225.30(b)(2). During the inspection excessive residue and buildup of medicated
articles were observed, and documented, in the bins of the (b)(4) equipment.
Additionally, the tank containing the liquid drug melengestrol acetate was contaminated with
dirt and insects. The debris observed could affect the function of the metering device causing
the medicated feed to not meet the intended potency.
The above is not intended as an all-inclusive list of deficiencies at your facility. As a manufacturer of medicated feeds, you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and implementing regulations. You should take prompt action to correct the noted violations, and you should establish procedures whereby such violations do not recur. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) of the Act, [21 U.S.C. § 360b(m)(4)(B)(ii)] and 21 C.F.R. § 514.115(c)(2). This letter constitutes official notification under the law.
Based on the results of the May 13-14, and May 18, 2009 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.
FDA acknowledges that, On June 22, 2009, we received your response to the FDA-483 issued on
May 18.2009. However, your proposed responses to the 483 are insufficient as follows:
1a Your response to the observation states you do not agree with the investigator's observation because you believe you comply with the regulation. The evidence presented by the investigators show that while you do have a line for each drug, you do not record how much is present for each specific lot of the drug. If there is more than one lot in house, they may all be recorded under one lot number.
1 b No records were provided to document your claims here.
1c This observation concerns the records showing (b)(4) times the normal amount of Monensin used in a day. The root cause for the discrepancy was not provided nor was the impact on product discussed.
1g No records were provided to document your claims here.
2b From the description, it is not clear if the specific identity including the lot number and
expiration date are maintained.
4b Whether or not the feed is consumed on the premises is irrelevant. Lot numbers need to be
maintained and tracked.
5a This was not confirmed by our investigation. No records were provided to the contrary.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the cGMP violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. Please send your response to Danial S. Hutchison, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District