FDA Inspection
USHIO GERMANY GmbHUSHIO GERMANY GmbH – FDA Inspection, May 18, 2017
Record Details
This FDA Inspection record concerns USHIO GERMANY GmbH, with an inspection on May 18, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Li Li (Issuing Officer)
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ID · ed4afce4-7447-471c-8302-1684f1094c18
Inspection Facts
- Inspection number
- 1017476
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 1003.10(a)FDA not notified of defect or noncompliance
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1040.20(d)(3)(ii)UV lamp labels permanent, legible
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of USHIO GERMANY GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2019 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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