FDA Inspection
Z-Medica, LLCZ-Medica, LLC – FDA Inspection, Apr 14, 2015
Record Details
This FDA Inspection record concerns Z-Medica, LLC, with an inspection on April 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Z-Medica, LLC
- Inspection Date
- April 14, 2015
- Product Type
- Devices
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ID · 0000264d-bb54-4bf1-b9f7-4058a8fef630
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925184
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Z-Medica, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 10, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 11, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 2, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Z-Medica, LLC
- FDA Inspection 1201291 - 2023-03-10
- FDA Inspection 1053178 - 2018-05-10
- FDA Inspection 777974 - 2012-04-11
- FDA Inspection 643589 - 2010-02-02
- FDA Inspection 626207 - 2009-11-03
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