FDA Inspection
MIS MedicalMIS Medical – FDA Inspection, Mar 16, 2011
Record Details
This FDA Inspection record concerns MIS Medical, with an inspection on March 16, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- MIS Medical
- Inspection Date
- March 16, 2011
- Product Type
- Biologics
View Company Profile
ID · 03d334eb-c274-48f5-94e4-d9925fd455b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 714230
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MIS Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for MIS Medical
- FDA Inspection 569909 - 2009-02-06
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