FDA Inspection
WISSNER-BOSSERHOFF GMBHWISSNER-BOSSERHOFF GMBH – FDA Inspection, Apr 25, 2024
Record Details
This FDA Inspection record concerns WISSNER-BOSSERHOFF GMBH, with an inspection on April 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5d7812e-d43f-4e50-a4c1-582bea0a26a3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1237594
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
FDA Citations
10- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(i)Documentation of software validation
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