FDA Inspection
Hebei Pukang Medical Instruments Co., Ltd.Hebei Pukang Medical Instruments Co., Ltd. – FDA Inspection, Jan 12, 2017
Record Details
This FDA Inspection record concerns Hebei Pukang Medical Instruments Co., Ltd., with an inspection on January 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · baa688cc-7c12-4e6f-bf40-fa9b209de292
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 999605
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 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 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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