FDA Inspection
Phelcom Technologies SAFDA Inspection 1232932 - Phelcom Technologies SA - March 14, 2024
Record Details
This FDA Inspection record concerns Phelcom Technologies SA, with an inspection on March 14, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1dc9a0ba-cb20-4681-9638-1499a8dce146
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232932
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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