Company
SwitzerlandBaitella AG, Zurich, Switzerland – FDA Inspections
Inspection records and compliance data for Baitella AG in Zurich. 3 FDA inspections on record, last inspected May 15, 2025.
Company Profile
This profile covers Baitella AG based in Zurich, Switzerland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 2, 2012. Last inspected May 15, 2025.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Procedures not adequately established or maintained1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1272814 |
| May 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 972333 |
| February 2, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 770268 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Baitella AG
FEI Number
3001415205
Address
Thurgauerstrasse 70, Zurich, Switzerland
Country
Switzerland
ID: 55a06e9f-7cfd-4cf2-a3dd-94ff800ed12b