FDA Inspection
Augusta Medical Systems, LLCAugusta Medical Systems, LLC – FDA Inspection, Jul 22, 2014
Record Details
This FDA Inspection record concerns Augusta Medical Systems, LLC, with an inspection on July 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Augusta Medical Systems, LLC
- Inspection Date
- July 22, 2014
- Product Type
- Devices
View Company Profile
ID · 7eca5083-83ac-4ea2-bd73-4a82e31e26e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897363
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(e)Documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
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 |
| September 23, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Augusta Medical Systems, LLC
- FDA Inspection 1066597 - 2018-04-23
- FDA Inspection 748019 - 2011-09-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.