FDA Inspection
Osteotech, Inc.Osteotech, Inc. – FDA Inspection, Dec 9, 2010
Record Details
This FDA Inspection record concerns Osteotech, Inc., with an inspection on December 9, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Osteotech, Inc.
- Inspection Date
- December 9, 2010
- Product Type
- Biologics
View Company Profile
ID · a8fc28ad-b446-407a-aa46-98ebff78bf69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699568
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.180(a)Design adequate to bar spread of CD"s
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Osteotech, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Osteotech, Inc.
- FDA Inspection 845705 - 2013-08-16
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