FDA Inspection 940328 — Kindeva Drug Delivery L.P.
The FDA completed an inspection of Kindeva Drug Delivery L.P. on Sep 1, 2015 in Northridge, CA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Northridge, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |