FDA Inspection 971066 — Bora Pharmaceuticals Laboratories, Inc
The FDA completed an inspection of Bora Pharmaceuticals Laboratories, Inc on Apr 15, 2016 in Miaoli County. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 15, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miaoli County (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |