FDA Inspection
Aerscher Diagnostics, LLCAerscher Diagnostics, LLC – FDA Inspection, Jun 21, 2024
Record Details
This FDA Inspection record concerns Aerscher Diagnostics, LLC, with an inspection on June 21, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d0671b6a-3cf1-4938-86d8-0ed37256497c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1241779
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Aerscher Diagnostics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 19, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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