FDA Inspection
Medfaxx, Inc.Medfaxx, Inc. – FDA Inspection, Jul 10, 2019
Record Details
This FDA Inspection record concerns Medfaxx, Inc., with an inspection on July 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cb0fea87-5db8-4d5c-8ec7-735cd205d156
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095771
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medfaxx, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 2, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medfaxx, Inc.
- FDA Inspection 975170 - 2016-06-13
- FDA Inspection 805892 - 2012-11-02
- FDA Inspection 679076 - 2010-09-02
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.