FDA Issues Warning Letter to Art of Beauty Company Over CGMPs

The US Food and Drug Administration (FDA) issued a Warning Letter to Art of Beauty Company, Inc., Bedford, OH. According to FDA, the facility is not compliance with Current Good Manufacturing Practice regulations for finished pharmaceuticals.

According to FDA:

1. AoB’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

2. AoB failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

3. AoB failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

4. AoB failed to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess (21 CFR 211.100(a)).

5. AoB 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, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)), and failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Based upon the nature of the violations, FDA recommended Art of Beauty hire a consultant qualified as set forth in 21 CFR 211.34 to assist in meeting CGMP requirements.