FDA Inspection
Amphastar Pharmaceuticals, Inc.Amphastar Pharmaceuticals, Inc. – FDA Inspection, Feb 12, 2019
Record Details
This FDA Inspection record concerns Amphastar Pharmaceuticals, Inc., with an inspection on February 12, 2019, issued by the Los Angeles District Office, covering human drugs.
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ID · b297f414-5cd0-46c7-a3cf-138b1f5293af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079028
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192No written record of investigation
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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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