Inspections, Compliance, Enforcement, and Criminal Investigations
Churchill Veterinary Supply Company, Inc. 18-Oct-06
Department of Health and Human Services
Public Health Service
Cincinnati District Office
October 18, 2006
VIA FEDERAL EXPRESS
Miriam E . Harthill, President
Churchill Veterinary Supply Company, Inc.
No. 50 Whitman Court
Irvine, CA 92617
Dear Ms. Harthill:
An inspection of your animal drug manufacturing facility, Churchill Veterinary Supply Company Inc., located at 3737 South 4th Street, Louisville, Kentucky 40214-1712, was conducted on July 6, 7, 11, 12, 14, and 17, 2006. During the inspection our investigator documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection verified that your firm manufactures, and/or relabels several animal drug products, including: Butecort Sweat, Fur-A-Sweat, Foot Freeze (a .k.a. Foot Paint), TIE-UP POWDER, AFTER FIRING PAINT, BLUE SPLINT BLISTER, LIQUID BLISTER, and SOLUBLE IODINE, NASCENT.
These products are drugs within the meaning of section 201(g) of the Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or because they are intended to affect the structure or function of man or animals. The Food and Drug Administration (FDA) is unaware of substantial scientific evidence that any of these products as manufactured by your firm are generally recognized by qualified experts as safe and effective for their labeled indications. Therefore, they are "new animal drugs" within the meaning of section 201(v) [21 U.S.C. § 321(v)] of the Act. These drugs are adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act because they are unsafe within the meaning of section 512 [21 U.S.C. § 360b] of the Act. Under section 512, a new animal drug is deemed to be unsafe unless an approved New Animal Drug Application (NADA) is in effect for the specific product in question. None of the new animal drugs manufactured and distributed by your firm are the subject of an approved NADA. We note that two of Churchill Veterinary Supply Company, Inc. products, BLUE SPLINT BLISTER and LIQUID BLISTER, contain mercury bichloride (mercuric chloride), a chemical that FDA believes is not safe and effective. FDA has reports of adverse drug reactions including deaths in animals resulting from the use of mercury containing blistering products. The FDA also has safety concerns for humans that handle these products.
As a manufacturer of animal drugs, the Act also imposes other requirements on your firm and its products. During the inspection of your firm, our investigator observed numerous violations of the Act. For instance, your drug products are misbranded under section 502(f)(1) [21 U.S.C.§ 352(f)(1)] of the Act in that their labeling fails to bear adequate directions for use and they are not exempt from this requirement under 21 CFR § 201.115 because they are unapproved new animal drugs. In addition, your drug products are misbranded under section 502(o) [21 U.S.C. § 352(o)] of the Act because they are manufactured in an establishment not duly registered under section 510 [21 U.S.C. § 360] of the Act, and the drug products have not been listed as required under section 510(j) [21 U.S.C. § 360(j)] of the Act. Your facility is not exempt from the registration and listing requirements under section 510(g) [21 U.S.C. § 360(g)] of the Act and 21 CFR § 207.10.
Your drug products are also adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351 (a)(2)(B)] of the Act in that the controls and procedures used to manufacture, process, pack, and hold them do not conform to current good manufacturing practice. For example:
There is no laboratory testing conducted to determine the identity or strength of the active ingredient for any finished drug product prior to release for sale and distribution [21 CFR § 211.165(a)]; and
Batch production and control records for the drug products are not reviewed by a quality control unit prior to release for sale and distribution [21 CFR § 211.192].
The FDA investigator presented her list of observed violations at the closeout of the inspection to Ms. Kimberly A. Coates-Smith, Vice-President.
The above-identified violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that drug products your firm manufactures are in compliance with the Act and the regulations promulgated under it. Federal agencies are advised of the issuance of all warning letters about drug products so that they may take this information into account when considering the award of contracts. Until FDA can confirm correction of the deficiencies noted above, this office can recommend disapproval of any new applications listing this site as a manufacturer of drugs.
You should take prompt action to correct deficiencies at your facility. Failure to do so may result in further regulatory action without notice. These actions include, but are not limited to, seizure and/or injunction.
You should notify this office within 15 working days of receipt of this letter of the corrective actions you plan to implement to address the deficiencies at your firm. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time frame within which corrective actions will be completed.
Your response should be addressed to: U.S. Food & Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attn: Charles S. Price, Compliance Officer. If you have any questions, you may address them to Mr. Price at (513) 679-2700 extension 165.
Carol A. Heppe