483
Gilead Sciences, Inc.FDA 483 - Gilead Sciences, Inc. - February 12, 2024
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Record Details
An FDA inspection of Gilead Sciences, Inc. in La Verne, CA, identified a significant deficiency in their manufacturing record-keeping practices. The firm failed to include unique identifiers for major equipment used in the production of drug product batches, specifically for AmBisome. This indicates a lapse in maintaining adequate batch production and control records.
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ID · 804a0723-492c-4179-9bbb-f60b83663c7a