FDA Inspection
Clarity Diagnostics, LLCClarity Diagnostics, LLC – FDA Inspection, May 8, 2019
Record Details
This FDA Inspection record concerns Clarity Diagnostics, LLC, with an inspection on May 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 92c79206-5d81-476d-9d90-f85493d2e3c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088913
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Clarity Diagnostics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Clarity Diagnostics, LLC
- FDA Inspection 1169763 - 2022-04-06
- FDA Inspection 833184 - 2013-05-23
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