FDA Inspection
Z-Medica, LLCZ-Medica, LLC – FDA Inspection, Nov 3, 2009
Record Details
This FDA Inspection record concerns Z-Medica, LLC, with an inspection on November 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Z-Medica, LLC
- Inspection Date
- November 3, 2009
- Product Type
- Devices
View Company Profile
ID · c26cd5d4-ab15-4d4f-8ed3-7821d6d80666
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626207
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.184DHR content
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 14, 2015 | VAI | 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 |
Other documents for Z-Medica, LLC
- FDA Inspection 1201291 - 2023-03-10
- FDA Inspection 1053178 - 2018-05-10
- FDA Inspection 925184 - 2015-04-14
- FDA Inspection 777974 - 2012-04-11
- FDA Inspection 643589 - 2010-02-02
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.