FDA Inspection 909650 — Gemini Packaging Ltd.
The FDA completed an inspection of Gemini Packaging Ltd. on December 19, 2014 in Richmond. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richmond (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |