FDA Inspection
Eclipse Medcorp, LLCEclipse Medcorp, LLC – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Eclipse Medcorp, LLC, with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bd03c004-a045-465d-b243-3101d82a7950
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071526
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Eclipse Medcorp, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 13, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2014 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Eclipse Medcorp, LLC
- FDA Inspection 981033 - 2016-08-05
- FDA Inspection 942433 - 2015-08-13
- FDA Inspection 907791 - 2014-12-15
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