FDA Inspection
Planer PLCPlaner PLC – FDA Inspection, Oct 13, 2016
Record Details
This FDA Inspection record concerns Planer PLC, with an inspection on October 13, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4d338eff-36db-40b3-8e61-ee483605e4b7
Inspection Facts
- Inspection number
- 991128
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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