FDA Inspection
Black Pearl VisionBlack Pearl Vision – FDA Inspection, Sep 2, 2011
Record Details
This FDA Inspection record concerns Black Pearl Vision, with an inspection on September 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Black Pearl Vision
- Inspection Date
- September 2, 2011
- Product Type
- Devices
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ID · c225a5dd-f482-44aa-808e-95111acad09f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742764
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Black Pearl Vision
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
Other documents for Black Pearl Vision
- FDA Inspection 1235862 - 2024-04-11
- FDA Inspection 1121945 - 2020-02-28
- FDA Inspection 895035 - 2014-09-11
- FDA Inspection 895034 - 2014-09-10
- FDA Inspection 742766 - 2011-09-02
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