FDA Inspection
Prospera CorporationProspera Corporation – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Prospera Corporation, with an inspection on October 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 522c58d5-25ac-40e0-a5ce-985a1300f596
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029410
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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