FDA Inspection
Beijing KES Biology Technology Co., Ltd.Beijing KES Biology Technology Co., Ltd. – FDA Inspection, Mar 20, 2015
Record Details
This FDA Inspection record concerns Beijing KES Biology Technology Co., Ltd., with an inspection on March 20, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 20, 2015
- Product Type
- Devices
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ID · d12f4a58-8023-419e-898b-ae0de1f8a43a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 921689
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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