Company
SwedenIntegrum Ab, Molndal, Sweden – FDA Inspections
Inspection records and compliance data for Integrum Ab in Molndal. 3 FDA inspections on record, 1 Form 483, last inspected September 08, 2022.
Company Profile
This profile covers Integrum Ab based in Molndal, Sweden.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 21, 2015. Last inspected September 8, 2022.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Complaints1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1180268 |
| August 29, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1063704 |
| May 21, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926999 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Integrum Ab
FEI Number
3011386779
Address
Gemenskapens gata 9, Molndal, Sweden
Country
Sweden
ID: de8ad86d-bba0-42ee-ae40-eedadbbfdf5c