FDA Inspection
Eclipse Medcorp, LLCEclipse Medcorp, LLC – FDA Inspection, Dec 15, 2014
Record Details
This FDA Inspection record concerns Eclipse Medcorp, LLC, with an inspection on December 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eclipse Medcorp, LLC
- Inspection Date
- December 15, 2014
- Product Type
- Devices
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ID · d141084d-92e6-4d63-9465-077baa8024cb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 907791
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 1002.11Failure to submit
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Other FDA inspections of Eclipse Medcorp, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 13, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eclipse Medcorp, LLC
- FDA Inspection 1071526 - 2018-11-09
- FDA Inspection 981033 - 2016-08-05
- FDA Inspection 942433 - 2015-08-13
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