| Public Health Service Food and Drug Administration |
Kansas City District Southwest Region 11630 W 80th Street Lenexa, KS 66214 Telephone: (913) 752-2100 |
Department of Health and Human Services
May 23, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2011-08
Kenneth E Knight, President
Knight Feedlot, Inc.
1768 Ave J
Lyons, Kansas 67554
Dear Mr. Knight:
An inspection of your licensed medicated feed mill located at 1768 Ave J, Lyons, Kansas conducted by the Food and Drug Administration (FDA) on December 14-17, 20-21, 2010 and January 4, 2011, documented significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225, (21 CFR 225). Such deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. 351 (a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found deviations including, but not limited to, the following:
1. Failure to maintain an original or copy of any record demonstrating that your firm investigated and took corrective action on any out of limits assay reports received, as required by 21 CFR 225.58 (d). For example, two separate assays of medicated feeds, one containing monensin and the other containing melengestrol acetate (MGA), were not within the permissible limits and no investigation or corrective action was documented.
2. Failure to maintain daily drug inventory records which contain the information as required by 21 CFR 225.42(b)(6)(i). For example:
- The inspection revealed that drugs stored in the Micro room are inventoried based on weight at the end of each day. Complete and partial bags of drugs are included in the daily inventory after the Micro machine bins are topped off. After the bins are topped off, the amount of drug in the bins is included in the daily drug inventory count if the bin has a load cell. Zilpaterol hydrochloride (Zilmax 4.8%) and Ractopamine (Optiflexx 45) are in bins without a load cell. The drugs in these bins were not counted in the daily drug inventory records.
- There are multiple examples of drug inventories that fail to exhibit the correct lot number. Examples include:
a) Invoice #(b)(4) shows the firm received a shipment of (b)(4)lb bags of Zilmax, lot number (b)(4) on (b)(4). However, this shipment was never entered in the Daily Drug Lot Number Use Record and none was found on site during the inspection. The Daily Drug Inventory Count Form showed lot (b)(4) (not lot (b)(4)) was used from (b)(4) – (b)(4).
b) The lot number recorded on the (b)(4) Daily Drug Lot Number Use Record for Zilmax was (b)(4); the only Zilmax observed on-site on 12/14/10 was a partial bag labeled as lot number (b)(4).
3. Failure to properly identify, store, handle and control drugs in the mixing areas to maintain their integrity and identity, as required by 21 CFR 225.42(b)(4). For example, a bag of Tylan 100 (Tylosin) did not contain the lot code and expiration date as they were removed upon opening.
4. Failure to maintain a complete and accurate Master Record File as required by 21 CFR 225.102 (b)(1).
The above is not intended as an all-inclusive list of deficiencies of your facility. As a licensed manufacturer of medicated feeds, you are responsible for assuring that the products your facility manufactures and distributes, as well as your overall operation, are in compliance with the Act and its implementing regulations. You should take prompt action to correct the noted violations and 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 CFR 514.115(c)(2). This letter constitutes official notification under the law.
Based on the results of the December 14-17, 20-21, 2010, January 4, 2011 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 manufactured 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 January 31, 2011, we received a response to the Form FDA-483 issued on January 4, 2011, from Mr. Mark Knight. Although it appears from the response that your firm is working towards correcting the deviations noted at your facility, we would like to take this opportunity to clarify your responsibilities as an operator of a licensed feed mill.
21 CFR 225.10 through 225.115 apply to feed mills manufacturing one or more medicated feeds for which an approved medicated feed mill license is required. Because you hold a medicated feed mill license, these regulations apply to the manufacture of all medicated feed at your facility. The regulations do not differentiate between medicated feed consumed by cattle under your firm’s control and medicated feed distributed to others.
21 CFR 225.30(b)(1) requires that all equipment possess the capability to produce a medicated feed of intended potency, safety, and purity. This requirement refers not only to the design of the equipment but also to whether the equipment does, in fact, produce a medicated feed of intended potency, safety, and purity.
Your response to Item 1 on the FDA Form-483 states, “The assays in question were for Rumensin and MGA, which as Category I drugs do not require any annual assays for compliance purposes. However, for quality control purposes, we periodically assay our feed and our standard practice is to collect another assay in the event an out of tolerance result is returned. In the future, we will document, on the out of tolerance assay that a subsequent assay will be taken.” Though you are correct that as a licensed feed mill, you are not required to assay medicated feeds containing Category I drugs, please note that any out of tolerance assay on any medicated feeds requires further investigation and corrective action. Please note that investigation goes beyond merely re-sampling subsequent production batches of medicated feed. It also includes such activities as reviewing production records, other available information and documenting corrective actions.
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.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District
-
No comments:
Post a Comment