FDA Inspection 704289 — Unipack LLC
The FDA completed an inspection of Unipack LLC on December 8, 2010 in South Plainfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 8, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |