FDA Inspection
Shenzhen Healthcare Electronic Technology Co LtdShenzhen Healthcare Electronic Technology Co Ltd – FDA Inspection, Oct 23, 2014
Record Details
This FDA Inspection record concerns Shenzhen Healthcare Electronic Technology Co Ltd, with an inspection on October 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 23, 2014
- Product Type
- Devices
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ID · 6110ceae-20c2-4c26-8b19-0e72f3dabb93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 904411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.120(d)Mixups
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - 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 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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