FDA Inspection
Regent Electron (Suzhou) Co., Ltd.Regent Electron (Suzhou) Co., Ltd. – FDA Inspection, Aug 15, 2024
Record Details
This FDA Inspection record concerns Regent Electron (Suzhou) Co., Ltd., with an inspection on August 15, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca89bdb4-a008-4b25-9d9c-c965161164dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1248311
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.180(b)Retention period
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