| Public Health Service Food and Drug Administration |
| Kansas City District Southwest Region 11630 W. 80th Street Lenexa, Kansas 66214 |
Department of Health and Human ServicesApril 30, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2010-04
Alan J. Svajgr, President
Darr Feedlots Inc.
1816 Ave H
Cozad, Nebraska 69130
Dear Mr. Svajgr:
On May 13-14, 2009, an inspection of your medicated feed mills located at Darr Feedlot, Inc. (North), 42826 Road 759, Cozad, Nebraska 69130 (Darr North) and Darr Feedlot, Inc. (South), 75429 Road 424, Cozad, Nebraska 69130 (Darr South), was conducted by a Food and Drug Administration (FDA) investigator and an inspector from the Nebraska Department of Agriculture on behalf of the FDA. On December 15-17, 2009, another inspection of Darr North and records from Darr South was conducted by an FDA investigator. These inspections documented the use of new animal drugs chlortetracycline and monensin in combination in cattle feed, contrary to the New Animal Drug Application (NADA) approvals for these drugs (see 21 CFR 558.128 and 21 CFR 558.355 for approved uses of chlortetracycline and monensin, respectively, in cattle feed). When combined in cattle feed, these drugs are unsafe within the meaning of section 512(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. §360b(a)(1)(A)], and adulterated within the meaning section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).Further, the feed bearing such drugs is unsafe within the meaning of section 512(a)(2)(B) of the Act, [21 U.S.C. 360b(a)(2)(B)], and adulterated within the meaning of section 501(a)(6) of the Act, [21 U.S.C. §351(a)(6)]. In addition, the May 13-14, 2009, inspection documented significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225). These deviations cause the medicated feed to be adulterated within the meaning of section 501(a)(2)(B) of the Act, [21 U.S.C. § 351(a)(2)(B)].
Our investigation found:
• The use of the drugs chlortetracycline and monensin in combination which are not approved to be used in combination in cattle feed. For example, during the May 13-14, 2009, inspection of Darr North, our investigation found that the facility had manufactured the following loads of an unapproved combination of chlortetracycline and monensin:
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
During the May 13-14, 2009, inspection of Darr South, our investigation found that the facility had manufactured the following loads of an unapproved combination of chlortetracycline and monensin in medicated feed:
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
o in Load #(b)(4), ration (b)(4) on (b)(4)
Additionally, during the December 15-17, 2009, inspection of Darr North and records from Darr South, our investigation found that both Darr North and Darr South had manufactured several loads of an unapproved combination of chlortetracycline and monensin in medicated feed between May 21, 2009 and June 5, 2009.
• Failure to establish and maintain adequate procedures for the identification and inventory control, including use, of all Type A medicated articles used in the manufacture of medicated feeds. [21 C.F.R. 225.142] For Example, at the North and South facilities, our investigation found on May 13, 2009, different lots of Type A medicated articles are mixed together in the micro machines without recording the lot numbers and therefore the identity of the drugs is lost.
The above is not intended as an all-inclusive list of deficiencies at your facility. 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.
You should take prompt action to correct the noted violations, and you should establish procedures whereby such violations do not recur. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, civil, and criminal penalties. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.
On June 24, 2009, we received your response to the FDA-483 issued on May 14, 2009. On January 19, 2010, we received your response to the FDA-483 issued on December 17, 2009. However, the responses were insufficient. We note that you continued to manufacture an unapproved combination of chlortetracycline and monensin in medicated feed after receiving the FDA-483 issued on May, 14, 2009.
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 regulations. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) 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 Danial S. Hutchison, Compliance Officer, at the above address.
Sincerely,
/s/
John W. Thorsky
District Director
Kansas City District
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