Company
FinlandBioretec Ltd, Tampere, Finland – FDA Inspections
Inspection records and compliance data for Bioretec Ltd in Tampere. 2 FDA inspections on record, 2 Form 483s, last inspected January 23, 2025.
Company Profile
This profile covers Bioretec Ltd based in Tampere, Finland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 22, 2018. Last inspected January 23, 2025.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Process changes - review, evaluation and revalidation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1259316 |
| February 22, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1044937 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bioretec Ltd
FEI Number
3005536892
Address
Yrittajankulma 5, Tampere, Finland
Country
Finland
ID: 34ca33da-554b-4198-852d-1b35a87fdf1e