FDA Inspection 1286864 — Kindeva Drug Delivery L.P.
The FDA completed an inspection of Kindeva Drug Delivery L.P. on November 13, 2025 in Northridge, CA. 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
- November 13, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Northridge, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4576 | 21 CFR 211.192 | No written record of investigation |