FDA Inspection
Aerscher Diagnostics, LLCAerscher Diagnostics, LLC – FDA Inspection, Jan 19, 2011
Record Details
This FDA Inspection record concerns Aerscher Diagnostics, LLC, with an inspection on January 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aerscher Diagnostics, LLC
- Inspection Date
- January 19, 2011
- Product Type
- Devices
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ID · 64b77b58-3fd6-4858-83c0-a0757905e1a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 705980
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Aerscher Diagnostics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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