FDA Inspection
Medisurge, LLC.Medisurge, LLC. – FDA Inspection, Aug 22, 2018
Record Details
This FDA Inspection record concerns Medisurge, LLC., with an inspection on August 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5dae2158-2724-471c-a049-17c40133cabe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062932
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Medisurge, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medisurge, LLC.
- FDA Inspection 1201252 - 2023-03-17
- FDA Inspection 909507 - 2015-01-15
- FDA Inspection 799522 - 2012-09-19
- FDA Inspection 705738 - 2010-10-04
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