FDA Inspection
Paragon Vision Sciences IncParagon Vision Sciences Inc – FDA Inspection, Sep 27, 2016
Record Details
This FDA Inspection record concerns Paragon Vision Sciences Inc, with an inspection on September 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Paragon Vision Sciences Inc
- Inspection Date
- September 27, 2016
- Product Type
- Devices
View Company Profile
ID · 5f98b52e-32bb-482a-af0e-c5ed02e89c9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988557
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(a)Production processes
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