FDA Inspection
STARS MICROELECTRONICS (THAILAND) PUBLIC COMPANY LIMITEDSTARS MICROELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED – FDA Inspection, Nov 16, 2017
Record Details
This FDA Inspection record concerns STARS MICROELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED, with an inspection on November 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 16, 2017
- Product Type
- Devices
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ID · a26ee104-4768-4615-98c2-947ce4929951
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032161
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.184DHR content
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