FDA Inspection
Encompass Group LLCEncompass Group LLC – FDA Inspection, Jul 2, 2026
Record Details
This FDA Inspection record concerns Encompass Group LLC, with an inspection on July 2, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 2202ca8b-4e8e-4e74-9754-120c2f4f1120
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1324952
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.5.1Changes to maintain QMS and device not identified and implemented
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Other FDA inspections of Encompass Group LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 10, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 26, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 22, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Encompass Group LLC
- FDA Inspection 1117785 - 2020-01-08
- FDA Inspection 1014247 - 2017-06-09
- FDA Inspection 827694 - 2013-04-10
- FDA Inspection 708183 - 2011-01-26
- FDA Inspection 636913 - 2009-12-22
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