Inspections, Compliance, Enforcement, and Criminal Investigations
Wilbur Ellis Company 27-Apr-05
Department of Health and Human Services
Public Health Service
Denver District Office
April 27, 2005
RETURN RECEIPT REQUESTED
Herbert B. Tully
Wilbur Ellis Company
345 California Street, 17th Floor
San Francisco, CA 94104
Ref # DEN-05-10
Dear Mr. Tully:
An inspection of your medicated feed mill, known as Knox McDaniel Company, 815 West 24h Street, Ogden, Utah, conducted by a Food and Drag Administration (FDA) investigator on December 20-22, 2004, 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, add Cosmetic Act (the Act), (Title 21 United States Code (U.S.C.), Section 351(a)(2)(B)). The investigation also revealed that you caused animal drugs to be misbranded within the meaning of 502(f)(1) of the Act (21 U.S.C. 352(f)(1)).
Our inspection disclosed the following serious deviations from the CGMP regulations:
1. Failure to conduct potency assays on at least three representative samples of each feed required to be manufactured by a licensed medicated feed mill at periodic intervals during the calendar year, [21 CFR 225.58(b)(1)].
Specifically, during the past year, you did not collect and assay any representative samples of your medicated feeds manufactured from the Type A, [redacted]. One such feed was the Type B cattle feed, [redacted]
2, Failure to maintain required master record files and production records, [21 CFR 225.102(b)].
Specifically, in two of five Master Record Files reviewed, manufacturing instructions were incomplete in that the mixing times were not specified, [21 CFR 225.102(b)(1)(iv)].
In addition; in six of six Batch Production Records reviewed, there was no indication that the records had been checked at the end of the working day in which the product was manufactured to determine whether all required production steps had been performed, [21 CFR 225.102(b)(4)].
Our investigator also noted that the labels on two cattle feeds contained no directions for use. The label for [redacted] stated "Feed according to [redacted] Nutrition''. The label for [redacted] stated "Feed according to [redacted] Dairy Nutrition." In addition, two medicated feeds, [redacted] and [redacted] when prepared and labeled according to a consultant's directions, would not provide the labeled potency when fed as directed. The [redacted] feed was superpotent by [redacted] and the [redacted] feed was subpotent by [redacted]. These products are misbranded under section 502(f)(1) of the Act (21 U.S.C. 352(1)(i)) because they do not bear adequate directions for use and they are not exempt from this requirement under 21 CFR 201.115.
The above is not intended as 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. We are aware of your discussion with the Investigator regarding the use of formulas and labels supplied by consultants not associated with your firm. Any feed manufactured by your firm, whether it is distributed under your label or another firm's label, must comply with all applicable laws and regulations. If you are manufacturing a product for another firm, either, they should supply you with appropriate formulas and labels or you should develop this information yourself.
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, 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 515.22(c)(2). (This letter constitutes official notification under the law of CGMP violations.) Based on the results of the December 20-22, 2004 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.
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 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: Food and Drug Administration, Denver District, P.O. Box 25087, Denver, CO 30225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions, please contact Mr. Sherer at (303) 236-3051.
B. Belinda Collins