FDA Inspection 759830 — Unit Dose Solutions, Inc.
The FDA completed an inspection of Unit Dose Solutions, Inc. on Dec 19, 2011 in Raleigh, NC. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Raleigh, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4414 | 21 CFR 211.204 | Record information maintained |