FDA Inspection 1208195 — Quality CDMO
The FDA completed an inspection of Quality CDMO on June 16, 2023 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |