FDA Inspection
Medart A /SMedart A /S – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Medart A /S, with an inspection on September 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medart A /S
- Inspection Date
- September 13, 2013
- Product Type
- Devices
View Company Profile
ID · b7351a72-ea04-4a85-9113-7e59bcdcf351
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849997
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medart A /S
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2018 | Not classified | Office of Inspections and Investigations | Radiation Control and Health Safety Act |
| September 24, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 1, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medart A /S
- FDA Inspection 1053704 - 2018-05-31
- FDA Inspection 944716 - 2015-09-24
- FDA Inspection 789470 - 2012-06-01
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.