FDA Inspection
MedX Holdings, Inc.FDA Inspection 837527 - MedX Holdings, Inc. - June 20, 2013
Record Details
This FDA Inspection record concerns MedX Holdings, Inc., with an inspection on June 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedX Holdings, Inc.
- Inspection Date
- June 20, 2013
- Product Type
- Devices
View Company Profile
ID · 7ab7ea91-43e1-4c5f-936a-4925ca50daaa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 837527
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MedX Holdings, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 19, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MedX Holdings, Inc.
- FDA Inspection 1017877 - 2017-07-11
- FDA Inspection 880730 - 2014-05-29
- FDA Inspection 653276 - 2010-03-19
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.