FDA Inspection
Stereo Optical Co IncStereo Optical Co Inc – FDA Inspection, Mar 18, 2014
Record Details
This FDA Inspection record concerns Stereo Optical Co Inc, with an inspection on March 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stereo Optical Co Inc
- Inspection Date
- March 18, 2014
- Product Type
- Devices
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ID · e607802e-3023-4ca2-b011-7fe66f45478d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869719
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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