FDA Inspection 797954 — KB Medical, Inc.
The FDA completed an inspection of KB Medical, Inc. on Sep 7, 2012 in Indianapolis, IN. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |
| 12361 | 21 CFR 1271.195(b) | Periodic inspection |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |