# FDA 483 - Gilead Sciences, Inc. - September 16, 2022

Source: https://www.keypedia.com/records/483/gilead-sciences-inc/438f558c-48b3-4ceb-8e01-7b80e37fce52

> FDA 483 for Gilead Sciences, Inc. on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Gilead Sciences, Inc. in La Verne, CA, a sterile drug manufacturer and testing laboratory, was cited for deficiencies in establishing and validating specifications, standards, and test procedures. The inspection revealed issues with the firm's methods for evaluating and recovering glass particulates from drug product vials, indicating potential quality control concerns.

## Related Documents

- [EIR - 2021-12-17](https://www.keypedia.com/records/eir/gilead-sciences-inc/d3233786-7ce8-48dc-a49a-3d9c19ea2e0b)
- [483 - 2021-12-17](https://www.keypedia.com/records/483/gilead-sciences-inc/f3bc99ad-a610-4254-85a1-0343996a2fe2)
- [483 - 2024-02-12](https://www.keypedia.com/records/483/gilead-sciences-inc/804a0723-492c-4179-9bbb-f60b83663c7a)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/gilead-sciences-inc/aef302cf-d6ca-423c-8e9a-4529b8be42ea

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6