Inspections, Compliance, Enforcement, and Criminal Investigations
Custom Feed Services Corporation 10-Nov-05
Department of Health and Human Services
Public Health Service
Kansas City District
November 10, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2006-02
Larry D. Smith, President
Custom Feed Services Corporation
P.O. Box 613
Norfolk, NB 68702-0613
Dear Mr. Smith:
An investigation of your medicated feed mill, License number [redacted] located at 2100 Highway 81 (North 13th Street), Norfolk, Nebraska conducted by a Food and Drug Administration (FDA) investigator on June 14th, 15th, 16th and 22nd, 2005 found significant deviations from the 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:
1) Master Record Files and production records are deficient in the following particulars:
a) the lack of complete manufacturing instructions for medicated feeds [21 CFR 225.102(b)(1)(iv)]
b) the lack of a copy or description of the label or labeling that will accompany the medicated feed [21 CFR 225.102(b)(1)(iii)]
c) the lack of control instructions for the sampling procedures regarding the manner and frequency of sample collections [21 CFR 225.102(b)(1)(v)]
d) the Master Record Files are not signed or initialed by a qualified person [21 CFR 225.102(b)(1)]
e) the batch production records are iioi teviewed at the end of the production run by a qualified person [21 CFR 225.102(b)(2)(i)].
2) There is no record the mineral oil scale is calibrated once a year. [21 CFR 225.30(b)(4)]
3) The facility is not maintained in a reasonably clean and orderly manner. [21 CFR 225.20(b)(2)]
4) You do not maintain a proper receipt record for each lot of drug received. For example, it was observed that lots of drugs identified in the drug inventory records as have being used despite the fact no receipt was shown in the drug records for that lot. [21 CFR 225.42(b)(5)].
The above is not intended as-an all-inclusive list of cGMP violations. As a manufacturer of medicated feeds, you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and implementing regulations.
In addition, during our investigation, we found feeds manufactured and distributed by your firm that contained Carbon black. The Act defines the term "color additive" at section 201(t)(1)(B) as a material which, when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting color thereto. Carbon black is a color additive. Color additives are deemed to be unsafe unless they are used in accordance with a color additive regulation that specifies the conditions under which the color additive may be safely used, including the purposes for which it may be used and the product category or categories to which it may be added [Section 721(a) of the Act]. There is no color additive regulation currently allowing for the use of carbon black in food, including animal feeds. Animal feeds containing carbon black are thus unsafe under section 721(a) and thus adulterated within the meaning of section 501(a)(4)(A) [21 U.S.C. 351(a)(4)(A)] of the Act..
In addition, we have determined that labels for your feeds containing monensin intended for use in dairy cattle are not in conformance with the approved application. Approval provides for feed to contain 11 to 22 g of monensin per ton (21 CFR 558.355(f)(3)(xiii)), but your labels for feeds containing monensin instead state the amount as mg/head/day. This labeling causes these feeds to be unsafe under section 512(a)(2) of the Act and thus adulterated within the meaning of section 501(a)(6) [21 U.S.C. 352(a)(6)] of the Act.
You should take prompt action to correct these cGMP violations. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions including, but not limited to, seizure, injunction and 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 CFR 515.22(c)(2).
Based on the results of the 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 constitutes official notification under the law and provides you an opportunity to correct the deficiencies in your operations.
You should also take immediate action regarding the other violations we have identified. You need to identify the specific steps that will correct the use of the unapproved color additive carbon black and the monensin labeling you routinely use.
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 achieve and maintain compliance with the law. Your response should include an explanation of each step being taken to correct the eGMP and other 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.
Please send your response to Ralph J. Gray, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District