FDA Inspection 1100840 — Biocon Biologics Limited
The FDA completed an inspection of Biocon Biologics Limited on August 30, 2019 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |