483
Columbia Cosmetics Manufacturing, Inc.FDA 483 - Columbia Cosmetics Manufacturing, Inc. - April 14, 2025
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Columbia Cosmetics Manufacturing, Inc. in San Leandro, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately investigate out-of-specification results, reject non-conforming drug products, and validate manufacturing processes and equipment cleaning. Additionally, issues were noted with component identity testing and vendor qualification for drug substances.
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