Company
SwitzerlandIvers-Lee AG, Burgdorf, Switzerland – FDA Inspections
Inspection records and compliance data for Ivers-Lee AG in Burgdorf. 2 FDA inspections on record, 2 Form 483s, last inspected March 22, 2023.
Company Profile
This profile covers Ivers-Lee AG based in Burgdorf, Switzerland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected July 5, 2019. Last inspected March 22, 2023.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Control procedures to monitor and validate performance1 inspection
- Manufacturing Instructions and Specifications1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1205537 |
| July 5, 2019 | VAI | Human Drugs · New Drug Evaluation | 1095767 |
FDA documents
Form 483s (2)
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Company Information
Name
Ivers-Lee AG
FEI Number
3002420194
Address
Kirchbergstrasse 160, Burgdorf, Switzerland
Country
Switzerland
ID: 3a8fcee6-5356-430c-a101-fe26decd992a