FDA Inspection
SURGIX MEDICAL LLCSURGIX MEDICAL LLC – FDA Inspection, Apr 2, 2019
Record Details
This FDA Inspection record concerns SURGIX MEDICAL LLC, with an inspection on April 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9b78bfc-96a5-4312-a2f2-d39e5e8109e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1084818
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of SURGIX MEDICAL LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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