FDA Inspection
A-T Surgical Company, LLCA-T Surgical Company, LLC – FDA Inspection, May 9, 2012
Record Details
This FDA Inspection record concerns A-T Surgical Company, LLC, with an inspection on May 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- A-T Surgical Company, LLC
- Inspection Date
- May 9, 2012
- Product Type
- Devices
View Company Profile
ID · 12ee65b1-c90b-48f4-850a-7f00656ec8ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780080
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of A-T Surgical Company, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for A-T Surgical Company, LLC
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.