FDA Inspection
Excelsior Medical LLCExcelsior Medical LLC – FDA Inspection, Jan 8, 2010
Record Details
This FDA Inspection record concerns Excelsior Medical LLC, with an inspection on January 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Excelsior Medical LLC
- Inspection Date
- January 8, 2010
- Product Type
- Devices
View Company Profile
ID · f1122da6-bd9f-4e51-9caa-8596cef965ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637937
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Excelsior Medical LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 29, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Excelsior Medical LLC
- FDA Inspection 985550 - 2016-07-20
- FDA Inspection 944051 - 2015-09-29
- FDA Inspection 893818 - 2014-08-21
- FDA Inspection 777712 - 2012-05-14
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