FDA Inspection
SOUTHWEST MEDICAL HOLDINGSSOUTHWEST MEDICAL HOLDINGS – FDA Inspection, Jul 27, 2018
Record Details
This FDA Inspection record concerns SOUTHWEST MEDICAL HOLDINGS, with an inspection on July 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cbd39107-8584-49dc-9552-9c77ee31dc3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061462
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.170(b)Installer records
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Equipment control activity documentation
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