Inspections, Compliance, Enforcement, and Criminal Investigations
Performance Products Inc 11/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
November 20, 2012
DELIVERED BY UPS
Ref. KAN 2012-02
Joseph R. Warnhoff, President
Performance Products Inc.
1212 Pierce Ave,
Saint Louis, MO 63110
Dear Mr. Warnhoff:
The Food and Drug Administration (FDA) conducted an inspection of your animal drug manufacturing facility, Performance Products Inc., located at 1212 Pierce Ave, Saint Louis, Missouri, from July 16-20, 2012. During this inspection, investigators from the FDA identified significant deviations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Part 211. These deviations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP. In addition, based on a review of your veterinary drug product labels your firm manufactures products which are misbranded under 21 U.S.C. §352(f) (section 502(f)) in that the labels do not have adequate directions for use. You can find the Act and FDA’s regulations through links on FDA’s Internet home page at http://www.fda.gov.
At the end of our inspection a Form FDA-483 with 8 Observations was issued. Although this inspection was conducted in July of 2012, we note that you have yet to respond to the Form FDA-483.
Current Good Manufacturing Practices Deviations
CGMP deviations observed during the inspection include, but are not limited to, the following:
- 21 CFR 211.180(c) requires all records under this part, or copies of such records, to be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. During our inspection you failed to provide the following records: records pertaining to batch production (21CFR211.188), records pertaining to equipment cleaning (21CFR211.67), and records regarding product stability testing (21CFR211.194). In fact, during the inspection your Vice President stated that your firm would not provide batch records, laboratory records, or product stability testing records for Triton Purrge Drops, (b)(4) and Biozide Gel.
This is a recurring observation from the April 2011 inspection of your firm..
- Under 21 CFR 211.84(d)(1) at least one test must be conducted on a sample to verify the identity of each component of a drug product. Our inspection found that you failed to perform identity testing for components of drug products received and used in the manufacture of animal drug products. For example, your firm did not conduct identity testing for (b)(4) and (b)(4) mineral oil as indicated during interviews and on testing documentation that management provided during the 2012 inspection. (b)(4) mineral oil is used to manufacture Triton Purrge Drops and (b)(4) is used in the manufacture of (b)(4).
This is a recurring observation from the April 2011, June 2006, September 2005 and September 2003 inspections of your firm.
- Under 21 CFR 211.166(a) there must be a written testing program to assess stability characteristics of all animal drug products. However, your firm has no written stability program for any of the products manufactured at your firm, including (b)(4), which is used to treat diarrhea in several animal species, and Purge, an oral laxative for cats and dogs and hairball removal in cats.
This is a recurring observation from the July 2001, September 2003, and April 2011 inspections of your firm.
- 21 CFR 211.100(a) requires that there be written procedures for production and process control designed to assure that drug products have the identity, strength, quality and purity they purport or are represented to possess. However, your firm is currently using “Cleaning and Maintenance of Production and Packaging Equipment”, “Sanitation Procedures”, and “Receiving Raw Materials and Packaging Materials” procedures, which are still in draft form. Triton Purrge Drops and (b)(4) are manufactured under these procedures.
This is a repeat observation from the April 2011 inspection of your firm.
- 21 CFR 211.67(b) requires written cleaning procedures to be established and followed for cleaning and maintenance of equipment used in the manufacture, processing, packing or holding of a drug product. However, there is no cleaning validation for the cleaning procedure “Cleaning and Maintenance of Production and Packaging Equipment”. You have equipment that is used for various products, including mixing tanks and a mixer. You can not show the cleaning procedure for equipment currently being used in the manufacturing of Triton Purrge Drops or (b)(4) is effective.
- 21 CFR 211.68(a) requires equipment used in the manufacture, processing, packing, and holding of a drug product to be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. However, at least four scales, including a (b)(4) scale, used in the animal drug manufacturing process were observed with calibration stickers that expired on 5-31-12. (b)(4) was manufactured (b)(4), as indicated by the manufacturing code, using the (b)(4) scale which was past the expiration of the calibration.
We have completed a label review and have concluded that your animal drugs Biozide Gel Wound Dressing and (b)(4), and (b)(4) ointment are misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] because they fail to identify the target species.
We request that you take prompt action to correct the current Good Manufacturing Practice deviations occurring at your firm. We also request you refrain from refusing to allow FDA investigators access to records which they lawfully have authority to inspect and copy.
Failure to promptly correct these violations of the Federal Food, Drug, and Cosmetic Act may result in enforcement action being initiated by the Food and Drug Administration without further notice. The federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products (section 304) [21 U.S.C. § 334] and for injunction against the manufacturers and distributors of illegal products (section 302) [21 U.S.C. § 332] and for prosecution of those who commit prohibited acts (section 301and 303) [21 U.S.C. § 331 and 333].
Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you will take, or have taken, to correct the violations identified in this letter and any other violations of the Act, and to assure that similar violations do not occur. Your response should include an explanation of each step being taken to achieve and maintain compliance with the regulations. Include copies of any available documentation demonstrating that corrections have been made. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
We remind you that under Section 512 of the Act, [21 U.S.C. 360b], to be legally marketed new animal drugs require approved or conditionally approved new animal drug applications, approved abbreviated new animal drug applications or listings on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (Index Listings). We note that your firm markets (b)(4) and Triton Purrge Drops without approved applications or index listings. You should be aware that, while we are not taking action against your products on this basis at this time, unapproved products that lack a required application or index listing are subject to FDA enforcement action to remove them from the market at any time. We also remind you that all drugs, whether marketed with an approval or not, must, among other things, be listed with the FDA as a registered firm; manufactured according to CGMP under 21 C.F.R. 211; and have labels and labeling that meet the requirements of the Act and its implementing regulations.
Please direct your response to Danial S. Hutchison, Compliance Officer, Food and Drug Administration, at the above letterhead address.
John W. Thorsky
Kansas City District