# FDA 483 - Cosmax USA, Inc. - March 17, 2020

Source: https://www.globalkeysolutions.net/records/483/cosmax-usa-inc/de558658-4f04-4d3f-82ed-05c9e00f2d2a

> FDA 483 for Cosmax USA, Inc. on March 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmax USA, Inc.
- Inspection Date: 2020-03-17
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Cosmax USA, Inc. in Solon, OH, an OTC drug manufacturer, was cited for significant deficiencies in its quality control unit, including inadequate investigations, lack of process validation, and insufficient stability testing for topical sunscreen drug products. The inspection revealed a systemic failure to adhere to cGMPs, impacting product quality, purity, and strength, and highlighting a lack of control over critical manufacturing processes and personnel training.

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## Related Officers

- [Program Analyst](https://www.globalkeysolutions.net/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

Company: https://www.globalkeysolutions.net/companies/cosmax-usa-inc/0417f27e-05b3-4176-8408-e1b48e834b3b

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22