Company
GermanyFischer ANalysen Instrumente GmbH, Leipzig, Germany – FDA Inspections
Inspection records and compliance data for Fischer ANalysen Instrumente GmbH in Leipzig. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected March 28, 2024.
Company Profile
This profile covers Fischer ANalysen Instrumente GmbH based in Leipzig, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected November 4, 2022. Last inspected March 28, 2024.
Most cited issue areas
- Design validation - software validation documentation1 inspection
- Equipment control activity documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1237711 |
| November 4, 2022 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1191129 |
FDA documents
Warning Letters (1)
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Company Information
Name
Fischer ANalysen Instrumente GmbH
FEI Number
3010837197
Address
Brahestr. 25-27, Leipzig, Germany
Country
Germany
ID: aee66f88-cb3c-4df8-8fc7-c598acbf7156