FDA Inspection
MedX Holdings, Inc.FDA Inspection 653276 - MedX Holdings, Inc. - March 19, 2010
Record Details
This FDA Inspection record concerns MedX Holdings, Inc., with an inspection on March 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedX Holdings, Inc.
- Inspection Date
- March 19, 2010
- Product Type
- Devices
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ID · f23a1c7d-3fb6-4bc7-8fe8-241ee8fa2dc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653276
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)(4)Verify, validate change {see also 820.100(a)}
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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 |
| June 20, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MedX Holdings, Inc.
- FDA Inspection 1017877 - 2017-07-11
- FDA Inspection 880730 - 2014-05-29
- FDA Inspection 837527 - 2013-06-20
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