Inspections, Compliance, Enforcement, and Criminal Investigations
Tennessee Farmers Cooperative 25-May-06
Department of Health and Human Services
Public Health Service
Now Orleans District
May 25, 2006
WARNING LETTER NO. 2006-NOL-07
Mr. Bart Krisle, CEO
Tennessee Farmers Cooperative
200 Waldron Road
LaVergne, TN 37086
Dear Mr. Krisle:
On November 11, 14, 15 and 17, 2005 and November 28, 29, 30 and December 1, 2005, investigators with the U.S. Food and Drug Administration (FDA) inspected your medicated feed mill, located at 4806 Co-op Road, Rockford, Tennessee. Samples obtained during our investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Samples of your equine feed, formula 93638, 10% Grain Mix, lot number 4287593638, collected during the investigation were analyzed by FDA's Forensic Chemistry Center (FCC). Analytical results reported by FCC on January 30, 2006, revealed the samples contained monensin at levels of 10.7 to 484 micrograms/gram (equivalent to ppm). Monensin is not approved for use in equine feed. The manufacture of equine feed containing monensin causes the feed to be deemed unsafe within the meaning of Section 512(a)(2)(A)(i) [21 USC 360b(a)(2)(A)(i)] of the Act and adulterated within the meaning of Section 501(a)(6) [21 USC 351(a)(6)] of the Act.
In addition, we are aware you conducted recalls of the following products due to monensin contamination: 10% Grain Mix, formula 93638, with the lot numbers 4276593638, 4283593638, 4287593638, and, 4290593638; and, 11% Sweet Horse Feed Course, lot number 43125327. You also recalled 16% Pelleted Goat Ration, lot number 4313593840, because the quantity of detectable Decoquinate was below specifications; Co-op Chick Starter/Grower, Medicated, lot numbers 43045104 and 43055104, because the quantity of detectable Amprolium was below specifications; and, Dairy Cattle Rumensin Premix 10000, Medicated Type B Premix, lot number 4287592997, because the amount of detectable Rumensin was below specifications.
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)(iv) [21 USC 360b(m)(4)(B)(iv)] of the Act and Title 21 Code of Federal Regulations, Part 515.22(c)(4) [21 CFR 515.22(c)(4)]. This letter constitutes official notice under the law. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
The above is not intended to be an all-inclusive list of violations. You are responsible for ensuring your overall operation, and the feed you distribute, is in compliance with the law. You should notify this office, in writing, within fifteen (15) working days of receiving 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 noted violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
M. Anthony Abel, I
Acting District Director
New Orleans District