FDA Inspection
NINGBO ALBERT NOVOSINO, LTD.NINGBO ALBERT NOVOSINO, LTD. – FDA Inspection, Jul 18, 2019
Record Details
This FDA Inspection record concerns NINGBO ALBERT NOVOSINO, LTD., with an inspection on July 18, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- NINGBO ALBERT NOVOSINO, LTD.
- Inspection Date
- July 18, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 5e28ccd6-c8c2-4954-b83a-10bfe09239f4
Inspection Facts
- Inspection number
- 1098236
- 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(a)Lack of or inadequate complaint 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
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