FDA Inspection 819296 — Amphastar Pharmaceuticals, Inc.
The FDA completed an inspection of Amphastar Pharmaceuticals, Inc. on February 6, 2013 in Rancho Cucamonga, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |