FDA Inspection
Fischer ANalysen Instrumente GmbHFischer ANalysen Instrumente GmbH – FDA Inspection, Nov 4, 2022
Record Details
This FDA Inspection record concerns Fischer ANalysen Instrumente GmbH, with an inspection on November 4, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 4, 2022
- Product Type
- Devices
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ID · 8d71fe7a-e331-4ce2-b3c9-e79c7f6a1cc0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1191129
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Fischer ANalysen Instrumente GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fischer ANalysen Instrumente GmbH
- FDA Inspection 1237711 - 2024-03-28
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