FDA Inspection 787992 — Amphastar Pharmaceuticals, Inc.
The FDA completed an inspection of Amphastar Pharmaceuticals, Inc. on Jun 28, 2012 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 28, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |
| 8914 | 21 CFR 314.81(b)(2)(iv)(b) | Mfg and control changes not requiring a supplemental app. |