FDA Inspection
SurgiFix, Inc.SurgiFix, Inc. – FDA Inspection, Aug 1, 2012
Record Details
This FDA Inspection record concerns SurgiFix, Inc., with an inspection on August 1, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- SurgiFix, Inc.
- Inspection Date
- August 1, 2012
- Product Type
- Biologics
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ID · e345f246-03e7-418b-aa68-7b8c35de4d55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792773
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.180(a)Procedures to meet core CTGP
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Other FDA inspections of SurgiFix, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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