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FDA Inspection
•rms Surgical, Inc.•May 15, 2015

rms Surgical, Inc. – FDA Inspection, May 15, 2015

Record Details

This FDA Inspection record concerns rms Surgical, Inc., with an inspection on May 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
rms Surgical, Inc.
Inspection Date
May 15, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · e8365684-dfdf-4cca-85bf-ca90e416b4f4

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
926479
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.198(c)Investigation of device failures
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.75(a)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of rms Surgical, Inc.

1
DateClassificationOfficeProject area
March 23, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for rms Surgical, Inc.
  • FDA Inspection 1045736 - 2018-03-23

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