FDA Inspection
Augusta Medical Systems, LLCAugusta Medical Systems, LLC – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Augusta Medical Systems, LLC, with an inspection on September 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Augusta Medical Systems, LLC
- Inspection Date
- September 23, 2011
- Product Type
- Devices
View Company Profile
ID · 3838075e-867a-4da3-88d2-e7bb91e5cb96
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Augusta Medical Systems, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Augusta Medical Systems, LLC
- FDA Inspection 1066597 - 2018-04-23
- FDA Inspection 897363 - 2014-07-22
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