FDA Inspection
Medical Quant USA Inc.Medical Quant USA Inc. – FDA Inspection, Sep 2, 2011
Record Details
This FDA Inspection record concerns Medical Quant USA Inc., with an inspection on September 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Quant USA Inc.
- Inspection Date
- September 2, 2011
- Product Type
- Devices
View Company Profile
ID · 2605b24a-d252-465a-b45d-ada58100e05d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 741513
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medical Quant USA Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Quant USA Inc.
- FDA Inspection 1197451 - 2023-02-06
- FDA Inspection 827472 - 2013-04-16
- FDA Inspection 802812 - 2012-10-10
- FDA Inspection 777307 - 2012-04-17
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.