# FDA 483 - G S Cosmeceutical USA Inc - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/g-s-cosmeceutical-usa-inc/2419bf93-73c5-4dda-909a-63ddc1a56e5a

> FDA 483 for G S Cosmeceutical USA Inc on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: G S Cosmeceutical USA Inc
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: G S Cosmeceutical USA Inc, an OTC/Rx drug manufacturer in Livermore, CA, was cited with six observations during an FDA inspection from August 12-14, 2019. The inspection revealed significant deficiencies in quality control unit procedures, GMP training, process validation, equipment qualification, facility space management, and equipment cleaning protocols. These issues indicate a lack of adherence to current Good Manufacturing Practices, posing potential risks to drug product quality and purity.

## Related Documents

- [483 - 2015-12-03](https://www.globalkeysolutions.net/records/483/g-s-cosmeceutical-usa-inc/93c3196d-3b52-40ce-a5ea-dd71613a4a5c)
- [483 - 2025-04-10](https://www.globalkeysolutions.net/records/483/g-s-cosmeceutical-usa-inc/6af8d152-5c8a-4d48-8d0a-1278714d69ee)

## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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