Inspections, Compliance, Enforcement, and Criminal Investigations
Central Connecticut Cooperative Farmers Association 13-May-08
Department of Health and Human Services
Public Health Service
New England District
VIA FEDERAL EXPRESS
May 13, 2008
Daniel Logue, President
Central Connecticut Cooperative Farmers Association
10 Apel Place
Manchester, Connecticut 06042
Dear Mr. Logue:
On January 25 and February 8, 2008, an investigator with the U.S. Food and Drug Administration (FDA) inspected your licensed medicated feed mill, located at 10 Apel Place, Manchester, Connecticut. Samples obtained during our investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, samples of your equine feed, 12% Equinator Integrity Horse Pellets, BH617, were found to contain the new animal drugs [redacted] (lasalocid sodium) and salinomycin. [redacted] (lasalocid sodium) and salinomycin are not approved for use in equine feed. Thus, the equine feed containing [redacted] (lasalocid sodium) and salinomycin is deemed to be unsafe within the meaning of section 512(a)(2) of the Act [21 U.S.C. § 360b(a)(2)] and adulterated within the meaning of section 501(a)(6) of the Act [21 U.S.C. § 351(a)(6)].
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 ensuring 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, and/or injunction.
We acknowledge receipt of your letter dated February 21, 2008, that responds to the Inspectional Observations, Form FDA-483, presented to Don Domina, General Manager at the close of inspection on February 8, 2008. We find the response inadequate because the response does not provide specific information about how you intend to prevent similar situations from occurring in the future. For example, the information you submitted does not address specific information with respect to procedures to be used in cleaning equipment prior to installation or use.
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 bring your firm into compliance with the law. 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 correction will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please send your written response to the U.S. Food and Drug Administration, Attention Bruce R. Ota, Compliance Officer, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Bruce I. Skolnick
Acting District Director
New England District
cc: Central Connecticut Cooperative Farmers Association Members