FDA Inspection 636220 — RM Medical
The FDA completed an inspection of RM Medical on Dec 30, 2009 in Carmel, 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
- Dec 30, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |