FDA Inspection
RM MedicalRM Medical – FDA Inspection, Dec 30, 2009
Record Details
This FDA Inspection record concerns RM Medical, with an inspection on December 30, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- RM Medical
- Inspection Date
- December 30, 2009
- Product Type
- Biologics
View Company Profile
ID · 8b27a8f4-4d4e-4b81-92f1-f4f4f374e14b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636220
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(b)Review and approval-responsible person
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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Other FDA inspections of RM Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for RM Medical
- FDA Inspection 774736 - 2012-03-28
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