FDA Inspection
NIPRO CANADA CORPORATIONNIPRO CANADA CORPORATION – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns NIPRO CANADA CORPORATION, with an inspection on May 31, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · 37a65377-189a-47bc-83fd-d789199ba978
Inspection Facts
- Inspection number
- 1053752
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of NIPRO CANADA CORPORATION
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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