COMPANY FAILS TO REPLY TO FORM FDA 483 FROM JULY 2012 AUDIT
Compliance Products, St. Louis, MO was audited by the Kansas City office of the FDA from July 16-20, 2012. Following the audit, a total of eight Observations were issued. As of the date of the Warning Letter, no response had been received by the FDA. Many of the Observations represented recurring Observations – including several Observations that had been issued on three previous occasions.
1) Observation #1 was of interest because of its reoccurrence based upon an audit from April 2011. The Company failed to produce records pertaining to 1) batch production, 2) equipment cleaning and 3) product stability testing. The FDA indicated that the Company’s VP indicated that the firm would not provide batch, laboratory or product stability testing records for several of their products, i.e., Triton Purrge Drops and Biozide Gel.
2) Observation #2 was involved with the failure to perform identity testing for components of drug products received and used in the manufacture of animal drug products. This included mineral oil used within the Triton Purrge Drops. Interestingly, this was a recurring Observation from 2001, 2003, and 2011.
3) The Investigators found that the Company possessed no written stability program for any of the products manufactured. This also represents a repeat Observation from 2001, 2003 and 2011.
4) Written procedures for “cleaning and Maintenance of production and packaging Equipment”, “sanitation Procedures” and “Receiving Raw Materials and packaging Materials” remain in Draft form. Again this is a repeat Observation from 2011.
5) Equipment that is used for various products, including mixing tanks and a mixer do not have cleaning procedures nor cleaning validations.
6) Equipment used in the manufacture, processing, packing and holding of a drug product is not routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Manufacturing was performed with a scale that was past its calibration expiration date.
It appears that the FDA has become impatient with the various actions of Performance Products. The FDA in the following paragraph warns the Company as to what may occur should they continue to disregard the issues observed by the FDA. It doesn’t appear that the Company has been reading the recent FDA enforcement reports which include seizures and other regulatory activities when a Company decides to ignore their wishes.
“We (the FDA) 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].”
The entire Warning Letter may be viewed at: http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/2012/ucm329738.htm