FDA Inspection 1102975 — R & B Medical Group Inc.
The FDA completed an inspection of R & B Medical Group Inc. on Sep 25, 2019 in Van Nuys, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- 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 |