Inspections, Compliance, Enforcement, and Criminal Investigations
FRM Chemical, Inc. 16-Mar-06
Department of Health and Human Services
Public Health Service
Kansas City District
March 16, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2006-15
Raymond Kastendieck, President
FRM Chemical, Inc.
Hwy 47 South
P.O. Box 207
Washington, MO 63090
Dear Mr. Kastendieck:
During recent inspections of your animal drug manufacturing facility located at Washington, Missouri, conducted on January 26-27, 2006 and April 27-29, 2005, our Investigator found significant deviations from the current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals [Title 21, Code of Federal Regulations, Part 211 (21 C.F.R. § 211)]. Such deviations cause animal drug products (such as your FRM Dine 1 Teat Dip Concentrate with Lanolin and Lanisyn 10 Teat Dip with 10% Glycerin & Lanolin products, both of which are labeled as "aid[s] in reducing the spread of mastitis-causing organisms in dairy animals") 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) [21 U.S.C. 301 et seq.].
Our investigation found the following:
Failure to perform at least one specific identity test on each drug component received, in lieu of testing each component for conformity with all appropriate written specifications for purity, strength, and quality [21 C.F.R. § 211.84(d)(2)].
Failure to establish and follow a written program for the calibration of instruments, apparatus, gauges, and recording devices used to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 C.F.R. § 211.160(b)(4)].
Failure to conduct GMP training on a continuing basis [21 C.F.R. § 211.25(a)].
Failure to establish written procedures describing the in-process controls and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch [21 C.F.R. §211.110 (a)].
Failure to establish written procedures designed to prevent objectionable microorganisms in drug product [21 C.F.R. §211.113(a)].
Failure to establish written control procedures for the issuance of labeling [21 C.F.R. § 211.125(f)]
Failure to establish written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities [21 C.F.R. §211.56(b)].
Failure to establish written procedures for evaluation, at least annually, the quality standards of each drug product [21. C.F.R. § 211.180(e)].
The above is not intended to be an all-inclusive list of violations. As a manufacturer of animal drug products, you are responsible for assuring 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 to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Federal agencies are advised of all Warning Letters about drugs so they may take this information into account when considering the award of contracts.
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 correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Also include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to the Food and Drug Administration, Attention: Joseph G. Kramer, Compliance Officer, at the address noted in the letterhead.
John W. Thorsky
Kansas City District