FDA Inspection
Medsource, Inc.Medsource, Inc. – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns Medsource, Inc., with an inspection on March 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medsource, Inc.
- Inspection Date
- March 31, 2015
- Product Type
- Devices
View Company Profile
ID · 40a032c7-6f1e-4774-8b71-0c17d98cec55
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 922246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.265(c)(1)Release of HCT/Ps by responsible person
- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Medsource, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 19, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 4, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Medsource, Inc.
- FDA Inspection 968327 - 2016-05-03
- FDA Inspection 791263 - 2012-07-19
- FDA Inspection 625859 - 2009-11-04
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