Company
United KingdomDe Soutter Medical Ltd, Aylesbury, United Kingdom – FDA Inspections
Inspection records and compliance data for De Soutter Medical Ltd in Aylesbury. 2 FDA inspections on record, 2 Form 483s, last inspected February 02, 2023.
Company Profile
This profile covers De Soutter Medical Ltd based in Aylesbury, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 26, 2018. Last inspected February 2, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1196589 |
| April 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050506 |
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
De Soutter Medical Ltd
FEI Number
3002948288
Address
Halton Brook Business Park, Weston Road, Aylesbury, United Kingdom
Country
United Kingdom
ID: 1a272dd7-824e-4fc9-b4fa-d3fdf2e65f70