| Public Health Service Food and Drug Administration |
| Baltimore District Central Region 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: 410-779-5455 FAX: 410-779-5707 |
Department of Health and Human ServicesFEI: 1111898
WARNING LETTER
CMS#166192
May 17, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
William A. Spillman III, President
Culpeper Farmers' Cooperative, Inc.,
dba CFC Farm Home Center
15172 Brandy Road
Culpeper, Virginia 22701
Dear Mr. Spillman:
An inspection conducted by the U.S. Food and Drug Administration (FDA) of your licensed medicated feed mill, located at 15172 Brandy Road in Culpeper, Virginia, between January 25 and February 11, 2011, found significant deviations from FDA regulations for Current Good Manufacturing Practice (CGMP) for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. Part 225). Such deviations cause medicated feeds manufactured, processed, packed, or held 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). Further, non-medicated feed manufactured, processed, packed, or held under insanitary conditions, whereby it may have become contaminated with filth, is deemed to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
Our investigation found that your firm's manufacturing processes did not conform to the CGMP requirements for medicated feeds. The deviations observed by our investigator during the inspection are as follows:
• The feed mill and warehouses were not maintained in a reasonably clean and orderly manner. The buildings were not maintained in a manner that would minimize access by rodents, birds and other pests, as required by 21 C.F.R. 225.20(b). Specifically, your facility contained spilled feed on the floor, broken and damaged feed bags, and a variety of trash, which provided a steady food supply, as well as harborage for rodents and other pests. Our investigators identified an infestation of mice and a large number of rodent excreta pellets throughout the facility. Further, the building disrepair provided numerous holes and other routes by which rodents were able to freely access the building. These same filth conditions also serve to adulterate the non-medicated feeds processed, packed or held in your facility.
• Drug components used in medicated feeds have not been properly controlled to assure their identity, strength, quality and purity once they are incorporated into a product as required by 21 C.F.R. 225.42. For example, our inspection identified rodent excreta pellets inside a bag of Deccox 6% (a Category I Type A medicated article).
• Deficiencies with drug component records were also found. While your firm has developed procedures and forms to keep these records, routine use of the forms and adherence to the CGMP requirements are inconsistent. For example, although the drug receipt record (see 21 C.F.R. 225.42(b)(5)) for Aureomycin 50 Granular identified that you have received (b)(4) shipments of product, the lot number is missing from (b)(4) entries and the condition of the shipment is missing from (b)(4) entries. Furthermore, the daily drug inventory (see 21 C.F.R. 225.42(b)(6)) needs to contain certain information, including the manufacturer's lot number or the feed manufacturer's shipment identification number, so that it could be used to track the use/disposition of each lot of drug on a daily basis, including the batches of feed in which each drug was used. The manufacturer's lot number was missing from numerous records, and no record contained the lot number of the medicated feed product in which the drug was used (see 21 C.F.R. 225.42(b)(7)). These requirements apply whether you are using Type A Medicated Articles or Type B Medicated Feeds as a drug source.
• Pesticides have not been handled and stored in a manner intended to prevent cross-contamination with feed products (see 21 C.F.R. 225.35). Our investigators identified the improper storage of an insecticide in the room you designated for drug storage, as well as the use of a rodenticide in other parts of the facility without adequate controls.
The above is not intended to be an all-inclusive list of 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 the violations described in this letter and to establish procedures whereby such violations do not recur.
Failure to promptly correct these violations 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) [21 U.S.C. 360b(m)(4)(B)(ii)] of the Act, and 21 C.F.R. 515.22(c)(2).
We acknowledge receipt of your letter dated March 3, 2011, explaining the steps you have initiated in response to the FDA-483 issued on 2/11/11 and re-issued on 2/17/11. Based on the results of the January/February 2011 inspection, together with the evidence before FDA when the Medicated Feed 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 drug therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. Your response should include an explanation of each step being taken to correct the CGMP violation 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.
Please send your reply to the Food and Drug Administration, Attention: Cherlita A. Honeycutt, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have questions regarding any issue in this letter, please contact Ms. Honeycutt at 410-779-5412.
Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office
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