FDA Inspection
Z-Medica, LLCZ-Medica, LLC – FDA Inspection, Apr 11, 2012
Record Details
This FDA Inspection record concerns Z-Medica, LLC, with an inspection on April 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Z-Medica, LLC
- Inspection Date
- April 11, 2012
- Product Type
- Devices
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ID · f1ed1f50-5418-490a-9a99-3ab7757693db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777974
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(e)Records of complaint investigation
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 |
| 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 925184 - 2015-04-14
- FDA Inspection 643589 - 2010-02-02
- FDA Inspection 626207 - 2009-11-03
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