# FDA 483 - G S Cosmeceutical USA Inc - December 03, 2015

Source: https://www.globalkeysolutions.net/records/483/g-s-cosmeceutical-usa-inc/93c3196d-3b52-40ce-a5ea-dd71613a4a5c

> FDA 483 for G S Cosmeceutical USA Inc on December 03, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: G S Cosmeceutical USA Inc
- Inspection Date: 2015-12-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: G S Cosmeceutical USA Inc, a contract drug manufacturer in Livermore, CA, was cited for significant deficiencies in its quality systems during an FDA inspection. Observations included failures in equipment cleaning validation, out-of-specification investigations, process validation, stability testing, and water system monitoring. Several issues, including OOS investigations and process validation, were repeat observations from a previous inspection, indicating persistent non-compliance.

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## Related Officers

- [Anh M. Lac](https://www.globalkeysolutions.net/people/anh-m-lac/20a897c2-ad8c-4bea-8060-34ba80d64d1e)

Company: https://www.globalkeysolutions.net/companies/g-s-cosmeceutical-usa-inc/02e5e566-9934-4417-9659-f041ee537843

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b