Company
DenmarkMedart A /S, Hvidovre, Denmark – FDA Inspections
Inspection records and compliance data for Medart A /S in Hvidovre. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected May 31, 2018.
Company Profile
This profile covers Medart A /S based in Hvidovre, Denmark.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 1, 2012. Last inspected May 31, 2018.
Most cited issue areas
- Failure to submit, distinct marking2 inspections
- Aperture label - laser radiation1 inspection
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 31, 2018 | Not classified | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1053704 |
| September 24, 2015 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 944716 |
| September 13, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 849997 |
| June 1, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 789470 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medart A /S
FEI Number
3005616124
Address
Industriholmen 15a, Hvidovre, Denmark
Country
Denmark
ID: ab57d5ff-3427-4a6e-8de0-632843e359f7