Inspections, Compliance, Enforcement, and Criminal Investigations
J.R. Simplot Company 17-Oct-05
Department of Health and Human Services
Public Health Service
October 17, 2005
RETURN RECEIPT REQUESTED
Lawrence S. Hoblik, CEO
J.R. Simplot Company
999 Main Street,
Boise, ID 83702
In reply refer to Warning Letter SEA 06-09
Dear Mr. Hoblik:
An inspection conducted by the Food and Drug Administration of your licensed medicated feed mill, Western Stockmen's, located at 223 Rodeo Avenue, Caldwell, Idaho, on July 11 and 15, 2005, found a significant deviation from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225 (21 CFR 225)). This deviation causes medicated feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) [United States Code (U.S.C.) 351 (a)(2)(13)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that your firm's manufacturing processes did not conform to cGMP requirements. The deviation observed by our investigator is as follows:
Western Stockmen's manufactured at least six batches of medicated feed containing amprolium, a Category 11, Type A medicated article, during calendar year 2004 without performing any assays. For feeds requiring an approved license for their manufacture and marketing (such as medicated feed containing amprolium), at least three representative samples of medicated feed containing each drug or drug combination used in the establishment shall be collected and assayed by approved methods, at periodic intervals during the calendar year (21 CFR 225.58).
Our investigator also noted that as of July 15, 2005, your medicated feed mill had not performed any assays on arnprolium-containing feeds yet this calendar year. Please keep in mind that you must collect and assay at least three representative samples of medicated feed containing each drug or drug combination used in the establishment by approved methods, at periodic intervals during 2005.
The inspection found an additional item that we would like to bring to your attention. Although the Corid 25% Amprolium found in your feed mill is labeled only for the manufacture of medicated feed for calves, we found that your firm is also using it to manufacture a Type B medicated feed, called Amprolium Premix, which is labeled for use in chickens, turkeys and pheasants, in addition to calves. If you wish to continue manufacturing medicated feeds for these other species, you should use a drug product that is labeled for use in these other species.
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 these violations and you should 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) of the Act and 21 CFR 515.22(c)(2).
Based on the results of the July 15, 2005 inspection, evaluated 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: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen