FDA Inspection
Omarc LlcOmarc Llc – FDA Inspection, Oct 28, 2016
Record Details
This FDA Inspection record concerns Omarc Llc, with an inspection on October 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5f0baaa4-1887-432a-9407-b135e863a146
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 991802
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Omarc Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Omarc Llc
- FDA Inspection 1150127 - 2021-08-11
- FDA Inspection 796293 - 2012-08-24
- FDA Inspection 769507 - 2012-03-01
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