FDA Inspection 965451 — Century Pharmaceuticals, Inc.
The FDA completed an inspection of Century Pharmaceuticals, Inc. on March 31, 2016 in Indianapolis, IN. 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 31, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |