In its letter, FDA summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. FDA stated “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” in its letter dated April 23, 2019.
During its inspection, our investigator observed specific violations including, but not limited to: failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Additionally, FDA said the facility “failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).”
Further, FDA said the firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, and purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
Clarins provided responses to FDA’s concerns, however, FDA asked for additional steps and tasks regarding the issues The full letter can be accessed here.
In its letter, FDA wrote: “Based upon the nature of the violations we identified at your firm and because you failed to correct repeat observations, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.”
The agency said that until the firm corrects all violations completely and compliance with CGMP is confirmed, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. Failure to correct these violations may also result in FDA refusing admission of articles manufactured at the specific Laboratoires Clarins facility into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).