FDA Inspection 752730 — Prescript Pharmaceuticals, Inc.
The FDA completed an inspection of Prescript Pharmaceuticals, Inc. on Nov 16, 2011 in Pleasanton, 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
- Nov 16, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasanton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |