FDA Inspection
rms Surgical, Inc.rms Surgical, Inc. – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns rms Surgical, Inc., with an inspection on March 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 870e3500-ce3e-4519-a988-20e2f2a3e7ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045736
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.184DHR content
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Other FDA inspections of rms Surgical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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