FDA Inspection 609825 — Amphastar Pharmaceuticals, Inc.
The FDA completed an inspection of Amphastar Pharmaceuticals, Inc. on Aug 19, 2009 in Rancho Cucamonga, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |