FDA Inspection
Black Pearl VisionBlack Pearl Vision – FDA Inspection, Apr 11, 2024
Record Details
This FDA Inspection record concerns Black Pearl Vision, with an inspection on April 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e4b75fd5-bf7b-4f8d-bd03-d94f64351bf5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235862
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Black Pearl Vision
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Black Pearl Vision
- FDA Inspection 1121945 - 2020-02-28
- FDA Inspection 895035 - 2014-09-11
- FDA Inspection 895034 - 2014-09-10
- FDA Inspection 742766 - 2011-09-02
- FDA Inspection 742764 - 2011-09-02
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