483
Amgen, Inc.FDA 483 - Amgen, Inc.
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Record Details
An FDA inspection of Amgen Inc.'s analytical laboratory in Thousand Oaks, CA, revealed deficiencies in method validation studies. Specifically, the firm failed to evaluate all recommended validation parameters, including demonstrating drug stability and method specificity. Additionally, the (b) (4) used in certain studies were not representative of those observed during subject sample analysis.
- Company
- Amgen, Inc.
- Product Type
- Drugs
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ID · a1384fcb-8ceb-4fff-b827-7aedea6283ba