FDA Inspection
Kabe Labortechnik GmbhKabe Labortechnik Gmbh – FDA Inspection, Jan 9, 2025
Record Details
This FDA Inspection record concerns Kabe Labortechnik Gmbh, with an inspection on January 9, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ef282848-4007-4ff1-921e-2fb0f1b595a3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1260617
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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