FDA Inspection
Galt Medical CorporationGalt Medical Corporation – FDA Inspection, Jan 19, 2011
Record Details
This FDA Inspection record concerns Galt Medical Corporation, with an inspection on January 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Galt Medical Corporation
- Inspection Date
- January 19, 2011
- Product Type
- Devices
View Company Profile
ID · ee592a59-1f67-45f8-a773-bb9b80726c23
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709001
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Galt Medical Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2026 | Not classified | Dallas District Office | |
| September 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Galt Medical Corporation
- FDA Inspection 1301774 - 2026-01-08
- FDA Inspection 996096 - 2016-09-15
- FDA Inspection 859195 - 2013-12-20
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.