FDA Inspection
BizLink Robotic Solutions FranceFDA Inspection 1254023 - BizLink Robotic Solutions France - October 31, 2024
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Record Details
This FDA Inspection record concerns BizLink Robotic Solutions France, with an inspection on October 31, 2024, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
- Inspection Date
- October 31, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 995268f8-7b2a-4ae9-a7ff-cef0b366a696
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1254023
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
9- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
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