# FDA 483 - Gilead Sciences, Inc. - December 17, 2021

Source: https://www.keypedia.com/records/483/gilead-sciences-inc/f3bc99ad-a610-4254-85a1-0343996a2fe2

> FDA 483 for Gilead Sciences, Inc. on December 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2021-12-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Gilead Sciences Inc. in La Verne, CA, a sterile drug manufacturer, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic process validation, quality control procedures, employee training, and facility maintenance. These issues primarily concern the manufacturing and storage of sterile injectable drug products, indicating a moderate level of non-compliance.

## Related Documents

- [EIR - 2021-12-17](https://www.keypedia.com/records/eir/gilead-sciences-inc/d3233786-7ce8-48dc-a49a-3d9c19ea2e0b)
- [483 - 2022-09-16](https://www.keypedia.com/records/483/gilead-sciences-inc/438f558c-48b3-4ceb-8e01-7b80e37fce52)
- [483 - 2024-02-12](https://www.keypedia.com/records/483/gilead-sciences-inc/804a0723-492c-4179-9bbb-f60b83663c7a)

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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