Inspections, Compliance, Enforcement, and Criminal Investigations
Central Connecticut COOP Farmer's Association 23-Jan-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
January 23, 2002
(President/Central Connecticut COOP Farmer?s Association)
200 Twin Hills Drive
Coventry, Connecticut 06238
Dear Mr. Peracchio:
An inspection of your medicated feed mill located in Manchester, Connecticut,
conducted by Food and Drug Investigator Michael Sinkevich on December 11 and 12,
2001, found significant deviations from Current Good Manufacturing Practice (CGMP)
regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225). Such deviations cause medicated feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The deviations are as follows:
1. For feeds requiring an approved license for their manufacture and marketing, 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
official methods, at periodic intervals during the calendar year. If the medicated feed
contains a combination of drugs, only one of the drugs need be subject to analysis
each time, provided the one tested is different from the one(s) previously tested. No
assays were performed in the years 2000 and 2001 (21 CFR 22558(b)(l)).
2. Adequate clean-out procedures for all equipment used in the manufacture and
distribution of medicated feeds are essential to maintain proper drug potency and to
avoid unsafe contamination of feeds with drugs. Your clean-out procedure fails to list
the Category II drugs histostat, rofenaid. Further, you do not include the holding units in the clean-out procedures.
3. Failure of your master record file to have adequate and approved formulations,
manufacturing instructions and labeling. For example, your current master record
file is dated October 22, 1979, and lacks adequate and approved formulations,
manufacturing instructions and labeling.
The above is not intended to be an all-inclusive list of CGMP 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.
Also noted during this investigation were rodent excreta pellets along the north wall of
your manufacturing facility where the bagged raw ingredients are warehoused.
Buildings and grounds shall be constructed and maintained in a manner to minimize
vermin and pest infestation.
You should take prompt action to correct these CGMP violations, and you should
establish procedures whereby such violations do not recur. Failure to promptly correct
these CGMP 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). . (This letter
constitutes official notification under the law.) Based on the results of the December 11
and 12, 2001 inspection, the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of the medicated fees are inadequate to assure
and preserve the identity, strength, quality, and purity of the new animal drugs therein.
This letter notifies you of our findings and provides you an opportunity to correct the
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 bring your firm into compliance with the law.
Your response should include an explanation of each step being taken to correct the
CGMP violations and prevent their recurrence. If corrective action cannot be completed
within thirty (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
demonstration that corrections have been made.
Your response should be directed to Bruce R. Ota, Compliance Officer, U.S. Food and
Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts
Gail T. Costello