Gilead Sciences, Inc.September 16, 2022

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

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Record Details

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.

Company: Gilead Sciences, Inc.
Inspection Date: September 16, 2022
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Nicholas L. Hunt (Senior CSO, Investigator)

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ID · 438f558c-48b3-4ceb-8e01-7b80e37fce52