FDA Inspection
MedX Holdings, Inc.FDA Inspection 1017877 - MedX Holdings, Inc. - July 11, 2017
Record Details
This FDA Inspection record concerns MedX Holdings, Inc., with an inspection on July 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedX Holdings, Inc.
- Inspection Date
- July 11, 2017
- Product Type
- Devices
View Company Profile
ID · 54fe70f6-cbb6-4e86-b478-cfa9c699d7d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017877
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of MedX Holdings, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2013 | OAI | 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 880730 - 2014-05-29
- FDA Inspection 837527 - 2013-06-20
- FDA Inspection 653276 - 2010-03-19
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