FDA 483 - Columbia Cosmetics Manufacturing, Inc. - January 29, 2020

An FDA inspection of Columbia Cosmetics Manufacturing, Inc. in San Leandro, CA, a contract drug and cosmetics manufacturer, revealed significant deficiencies in their quality system and laboratory controls. Observations included failures to conduct annual drug product reviews, inadequate microbiological testing for OTC products, and the release of drug products that did not meet pH specifications. The firm also failed to investigate out-of-specification results and had deficient cleaning validation procedures for equipment.