FDA Inspection
Amgen Inc.Amgen Inc. – FDA Inspection, Nov 30, 2023
Record Details
This FDA Inspection record concerns Amgen Inc., with an inspection on November 30, 2023, issued by the Cincinnati District Office.
- Company
- Amgen Inc.
- Inspection Date
- November 30, 2023
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ID · 14d042ef-b33c-4176-b9f0-33cd3b204f96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223903
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
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Other FDA inspections of Amgen Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2025 | Not classified | Cincinnati District Office | |
| January 17, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amgen Inc.
- FDA Inspection 1261008 - 2025-02-04
- FDA Inspection 1228575 - 2024-01-17
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