Company
SwitzerlandObtech Medical Sarl, Le Locle, Switzerland – FDA Inspections
Inspection records and compliance data for Obtech Medical Sarl in Le Locle. 3 FDA inspections on record, last inspected June 11, 2015.
Company Profile
This profile covers Obtech Medical Sarl based in Le Locle, Switzerland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 15, 2009. Last inspected June 11, 2015.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 935309 |
| September 15, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 743980 |
| January 15, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 563061 |
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
Obtech Medical Sarl
FEI Number
3005992282
Address
Chemin Blanc 38, Le Locle, Switzerland
Country
Switzerland
ID: 8d48d460-07f5-4218-8c03-5a6b24686f07