816876
KDNA Life Sciences LLC — FEI 3020499006
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 1, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Belgrade, MT (United States)
Citations
| ID | CFR | Description |
|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12349 | 21 CFR 1271.190(c) | Control system |
| 12469 | 21 CFR 1271.350(a)(1) | Adverse reaction reporting to FDA |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |