FDA Inspection
Medsource International LLCMedsource International LLC – FDA Inspection, Jan 6, 2017
Record Details
This FDA Inspection record concerns Medsource International LLC, with an inspection on January 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 61b1a71a-9489-4f2b-a189-2c16754fc06a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048861
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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Other FDA inspections of Medsource International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medsource International LLC
- FDA Inspection 1231118 - 2024-01-18
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