FDA Inspection 1075923 — Bora Pharmaceuticals Inc.
The FDA completed an inspection of Bora Pharmaceuticals Inc. on Dec 19, 2018 in Maple Grove, MN. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maple Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |