FDA Inspection 1177392 — Vero Biotech Inc
The FDA completed an inspection of Vero Biotech Inc on Aug 12, 2022 in Atlanta, GA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 12, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |