FDA Inspection 1228002 — Episciences Inc
The FDA completed an inspection of Episciences Inc on Jan 29, 2024 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 29, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |