FDA Inspection
Shi Heng Technology Co., Ltd.Shi Heng Technology Co., Ltd. – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns Shi Heng Technology Co., Ltd., with an inspection on August 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 25, 2016
- Product Type
- Devices
View Company Profile
ID · c61d1bdd-5228-4893-8e92-f6fab5916a7d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 987018
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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