FDA Inspection
PRS Medical Technologies Inc.PRS Medical Technologies Inc. – FDA Inspection, Dec 19, 2016
Record Details
This FDA Inspection record concerns PRS Medical Technologies Inc., with an inspection on December 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb09457c-128e-4840-a134-1ff900b611c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000138
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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