FDA Inspection
Excelsior Medical LLCExcelsior Medical LLC – FDA Inspection, Sep 24, 2010
Record Details
This FDA Inspection record concerns Excelsior Medical LLC, with an inspection on September 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Excelsior Medical LLC
- Inspection Date
- September 24, 2010
- Product Type
- Devices
View Company Profile
ID · f1de9b73-8d43-495f-9dbd-ad45c6cff4ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682455
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Excelsior Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Excelsior Medical LLC
- FDA Inspection 894469 - 2014-08-12
- FDA Inspection 777713 - 2012-05-14
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