FDA Inspection
Ushio America, Inc.Ushio America, Inc. – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Ushio America, Inc., with an inspection on May 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · e7db790d-3ced-49e7-9cec-d39b5cc86b99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053875
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.80(e)Documentation
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