FDA Inspection 1165331 — Unipack LLC
The FDA completed an inspection of Unipack LLC on March 25, 2022 in South Plainfield, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 25, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |