1102975
R & B Medical Group Inc. — FEI 3011425900
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12331 | 21 CFR 1271.170(a) | Sufficient number |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12438 | 21 CFR 1271.270(b) | Management system re: core CGTPs |