FDA Inspection
Delva Tool & Machine Crp adba Delva Medical Technologies LLCDelva Tool & Machine Crp adba Delva Medical Technologies LLC – FDA Inspection, Jun 6, 2013
Record Details
This FDA Inspection record concerns Delva Tool & Machine Crp adba Delva Medical Technologies LLC, with an inspection on June 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 6, 2013
- Product Type
- Devices
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ID · 9b65c835-6eb7-401d-8d69-71435097523d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833472
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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