Inspections, Compliance, Enforcement, and Criminal Investigations
Valley Feed Company 07-Oct-02
Department of Health and Human Services
Public Health Service
Baltimore District Office
October 7, 2002
CERTIFIED MAIL - RETURN RECEIPT REQUESTED
Mr. Robert H. Nutt, President
Valley Feed Company
Staunton, Virginia 24401
Dear Mr. Nutt:
An investigation of your medicated feed mill located at 316 New Hope Road, Staunton, Virginia,conducted by a Food and Drug Administration investigator on June 27-28, 2002 found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations (CFR), Part 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 (FD&C Act).
The investigation revealed that you are also manufacturing "Heifer W/TM50 & Rumensin" a bulk, custom made, medicated feed that contains Oyxtetracycline and Monensin, a drug combination that is not approved for use in dairy cattle, as per Title 21 CFR Part 558.450. The use of this combination renders the medicated feed adulterated within the meaning of Section 501(a)(6) of the FD&C Act in that it is an animal feed bearing or containing a new animal drug combination that is unsafe within the meaning of Section 512 of the FD&C Act.
The deviations from the CGMPs for Medicated Feeds, 21 CFR Part 225, include the following:
> Production records are not prepared for any batches or production runs of medicated feeds, as required by 21 CFR 225.102(a)&(b).
>Master record files for medicated feeds are not maintained or reviewed as required by 21 CFR 225.102(a) &(b). For example, the master formula identifies chlortetracycline as an ingredient whereas oxytetracycline was actually used to formulate the medicated feeds. Labels and/or labeling are not always included in the master record file. All of the manufacturing procedures (mixing directions and times) are not included the master record file. The formulations contained in the master records are not signed, initialed or dated. Formulations contain hand written changes with no indication that the changes were approved.
>Drug inventory records required by 21 CFR 225.42 are not complete or improperly completed. For example, the drug inventory record for Rumensin does not contain an entry showing that this drug was used in the manufacture of Heifer W/TM50 and Rumensin on 6/14/02. Drug inventory records do not contain lot numbers.
> Labeling that includes adequate information for the safe and effective use of the medicated feed is not provided to customers of bulk medicated feeds, as required by 21 CFR 225.80(b)(3).
> Feed labels for bagged feeds do not always contain all of the information required by 21 CFR 225.80(a). For example, the labeling for Heifer Mix and Valley 16% Calf Mix in 50 pound bags lack portions of the required caution statement; and the labeling for Littermate R with Rumensin 80 lacks the drug level, a complete caution statement, and complete feeding instructions.
The above is not intended to be an all-inclusive list of CGMP violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct these CGMP violations, and you should establish procedures
whereby such violations do not recur. Failure to promptly correct these CGMP violations may result in regulatory and/or administrative sanctions: These sanctions include 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 and 21 CFR 515.22(c)(2). This letter constitutes official notification under the law. Based on the results of the June 27-28, 2002 inspection, evaluated together with the evidence before FDA when the Form FDA 1900s were 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.
Until the CGMP violations have been corrected and the corrections verified by the FDA, the Center for Veterinary Medicine will not approve medicated feed applications for your facility.
You should notify this office in writing within thirty (30) 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 30 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.
Your response should be directed to Ms. Rosalie Bucey, Compliance Officer, 6000 Metro Drive, Suite
101, Baltimore, Maryland 21215. If you have any questions, you may contact her at telephone number
Director, Baltimore District