FDA Inspection 1046277 — Prescript Pharmaceuticals, Inc.
The FDA completed an inspection of Prescript Pharmaceuticals, Inc. on March 30, 2018 in Pleasanton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasanton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |