Company
SwedenDirecta AB, Upplands Vasby, Sweden – FDA Inspections
Inspection records and compliance data for Directa AB in Upplands Vasby. 1 FDA inspection on record, 1 Form 483, last inspected September 05, 2019.
Company Profile
This profile covers Directa AB based in Upplands Vasby, Sweden.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected September 5, 2019.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Software validation for automated processes1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1101420 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Directa AB
FEI Number
3004586882
Address
Finvids Vag 8, Upplands Vasby, Sweden
Country
Sweden
ID: ff1835fd-768d-4c46-af39-c9216435f803