FDA Inspection 997766 — Bora Pharmaceuticals Injectables Inc
The FDA completed an inspection of Bora Pharmaceuticals Injectables Inc on December 20, 2016 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |