FDA Inspection
Amphastar Pharmaceuticals, Inc.Amphastar Pharmaceuticals, Inc. – FDA Inspection, Jun 28, 2012
Record Details
This FDA Inspection record concerns Amphastar Pharmaceuticals, Inc., with an inspection on June 28, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 28, 2012
- Product Type
- Drugs
View Company Profile
ID · c62744d8-8ad5-48d5-80a1-6875ac45f3ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787992
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 310.305(c)Failure to submit ADE report
- 21 CFR 314.81(b)(2)(iv)(b)Mfg and control changes not requiring a supplemental app.
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.