FDA Inspection
PARAGON VISION SCIENCES, IncPARAGON VISION SCIENCES, Inc – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns PARAGON VISION SCIENCES, Inc, with an inspection on April 26, 2019, issued by the Denver District Office, covering medical devices & rad health.
- Company
- PARAGON VISION SCIENCES, Inc
- Inspection Date
- April 26, 2019
- Product Type
- Medical Devices & Rad Health
- Office
- Denver District Office
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ID · 38ab94f6-b3e1-43cc-b9a2-5f88f5cd7e8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089401
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of PARAGON VISION SCIENCES, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for PARAGON VISION SCIENCES, Inc
- FDA Inspection 1175438 - 2022-05-26
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