Company
SwedenCenova AB, Mjolby, Sweden – FDA Inspections
Inspection records and compliance data for Cenova AB in Mjolby. 3 FDA inspections on record, 1 Form 483, last inspected May 08, 2025.
Company Profile
This profile covers Cenova AB based in Mjolby, Sweden.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 12, 2019. Last inspected May 8, 2025.
Most cited issue areas
- DHR content1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 8, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1269851 |
| November 18, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1194250 |
| April 12, 2019 | Not classified | Medical Devices & Rad Health | 1090521 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cenova AB
FEI Number
3005216725
Address
Florettgatan 4, Mjolby, Sweden
Country
Sweden
ID: d4ee8c27-2f15-46f7-9265-d7a5afacc0f4