FDA Inspection
Galt Medical CorporationGalt Medical Corporation – FDA Inspection, Dec 20, 2013
Record Details
This FDA Inspection record concerns Galt Medical Corporation, with an inspection on December 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Galt Medical Corporation
- Inspection Date
- December 20, 2013
- Product Type
- Devices
View Company Profile
ID · 32d5b013-eb01-4015-9abe-d845df87a017
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859195
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.250(b)Sampling plans
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 |
| January 19, 2011 | 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 709001 - 2011-01-19
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