FDA Inspection
GSource, LLCGSource, LLC – FDA Inspection, Jul 30, 2024
Record Details
This FDA Inspection record concerns GSource, LLC, with an inspection on July 30, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eb6c05b0-31e6-4ee5-ad8b-e27cef6c2b5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245203
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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