FDA Inspection
Pro-Optics LLCPro-Optics LLC – FDA Inspection, Mar 11, 2026
Record Details
This FDA Inspection record concerns Pro-Optics LLC, with an inspection on March 11, 2026, issued by the Chicago District Office, covering medical devices & rad health.
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ID · 723fd26a-e797-46ac-bd94-a99c65b6d57b
Inspection Facts
- Inspection number
- 1306858
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
- ISO 13485:2016 Clause 7.3.4Records of design and development outputs not maintained
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Other FDA inspections of Pro-Optics LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pro-Optics LLC
- FDA Inspection 1037062 - 2018-01-03
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