FDA Inspection
Excelsior Medical LLCExcelsior Medical LLC – FDA Inspection, Sep 29, 2015
Record Details
This FDA Inspection record concerns Excelsior Medical LLC, with an inspection on September 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Excelsior Medical LLC
- Inspection Date
- September 29, 2015
- Product Type
- Devices
View Company Profile
ID · dc48f566-255e-4d38-91d1-dfe6a8592f52
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 944051
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| January 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Excelsior Medical LLC
- FDA Inspection 985550 - 2016-07-20
- FDA Inspection 893818 - 2014-08-21
- FDA Inspection 777712 - 2012-05-14
- FDA Inspection 637937 - 2010-01-08
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