FDA Inspection
RAYSEARCH LABORATORIES ABRAYSEARCH LABORATORIES AB – FDA Inspection, Nov 17, 2022
Record Details
This FDA Inspection record concerns RAYSEARCH LABORATORIES AB, with an inspection on November 17, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RAYSEARCH LABORATORIES AB
- Inspection Date
- November 17, 2022
- Product Type
- Devices
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ID · fd3cedba-24a3-447a-99d9-11f49d78080d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1191127
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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