# FDA 483 - Columbia Cosmetics Manufacturing, Inc. - April 14, 2025

Source: https://www.globalkeysolutions.net/records/483/columbia-cosmetics-manufacturing-inc/a5011ffd-0933-428e-971d-cc1594227240

> FDA 483 for Columbia Cosmetics Manufacturing, Inc. on April 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Columbia Cosmetics Manufacturing, Inc.
- Inspection Date: 2025-04-14
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: 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.

## Related Documents

- [483 - 2020-01-29](https://www.globalkeysolutions.net/records/483/columbia-cosmetics-manufacturing-inc/6541c253-5c99-4f18-8a4a-6a936ce6a3c8)
- [WARNING_LETTER - 2025-04-14](https://www.globalkeysolutions.net/records/warning_letter/columbia-cosmetics-manufacturing-inc/303534c7-8299-464e-85bd-bb894ffdcaa8)

## Related Officers

- [Nathan E. Hellman](https://www.globalkeysolutions.net/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Statistical Science Director](https://www.globalkeysolutions.net/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.globalkeysolutions.net/companies/columbia-cosmetics-manufacturing-inc/c6e32c25-080a-4901-8391-8716d6517687

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df