Hand Sanitizer Manufacturer Receives FDA Warning Letter Over CGMPs

The US Food and Drug Administration issued a Warning Letter to Sani-Care Salon Products, Inc., Cartersville, GA. FDA cited several violations, including:

• Failure by the quality control unit to exercise its responsibility to ensure drug products manufactured are in compliance with Current Good Manufacturing Practices (CGMP), and meet established specifications for identity, strength, quality and purity (21 CFR 211.22).

• Failure to have for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. FDA said Sani-Care also 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(a) and 211.165(b)).

• Failure to conduct at least one test to verify the identity of each component of a drug product. FDA said Sani-Care also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).