FDA Inspection 923349 — Episciences Inc
The FDA completed an inspection of Episciences Inc on April 10, 2015 in Boise, ID. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 10, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |