FDA Inspection
Modern Surgical IncModern Surgical Inc – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns Modern Surgical Inc, with an inspection on December 11, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Modern Surgical Inc
- Inspection Date
- December 11, 2008
- Product Type
- Biologics
View Company Profile
ID · 767a0086-8b9f-43bb-a313-1dd598ac372d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 551933
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Modern Surgical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 22, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Modern Surgical Inc
- FDA Inspection 773352 - 2012-03-19
- FDA Inspection 622889 - 2009-10-22
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