FDA Inspection 1261583 — Summit Biosciences Inc.
The FDA completed an inspection of Summit Biosciences Inc. on February 21, 2025 in Lexington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |