FDA Inspection 1074858 — Unipack LLC
The FDA completed an inspection of Unipack LLC on Dec 18, 2018 in South Plainfield, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 18, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |