FDA Inspection
Amphastar Pharmaceuticals, Inc.Amphastar Pharmaceuticals, Inc. – FDA Inspection, Feb 6, 2013
Record Details
This FDA Inspection record concerns Amphastar Pharmaceuticals, Inc., with an inspection on February 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 6, 2013
- Product Type
- Drugs
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ID · da068a9c-2649-4e8f-8ff6-e991d62bf741
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 819296
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
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Other FDA inspections of Amphastar Pharmaceuticals, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2025 | Not classified | Los Angeles District Office | |
| April 3, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 1, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amphastar Pharmaceuticals, Inc.
- FDA Inspection 1290538 - 2025-11-07
- FDA Inspection 1266798 - 2025-04-03
- FDA Inspection 1229403 - 2024-03-01
- FDA Inspection 1144508 - 2021-06-22
- FDA Inspection 1113865 - 2019-11-22
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