FDA Inspection
Suzhou Medical Appliance FactorySuzhou Medical Appliance Factory – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns Suzhou Medical Appliance Factory, with an inspection on November 9, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- November 9, 2017
- Product Type
- Medical Devices & Rad Health
- Person
- Amy M. Cramer (Issuing Officer)
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ID · d7d880af-ce12-4b6e-9193-a81758ded456
Inspection Facts
- Inspection number
- 1032182
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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