FDA Inspection
Shenzhen Creative Industry Co., Ltd.Shenzhen Creative Industry Co., Ltd. – FDA Inspection, Aug 6, 2015
Record Details
This FDA Inspection record concerns Shenzhen Creative Industry Co., Ltd., with an inspection on August 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 6, 2015
- Product Type
- Devices
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ID · dc959468-fb31-4679-9297-f6d298abc3f6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940774
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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Other FDA inspections of Shenzhen Creative Industry Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2018 | Not classified | Office of Inspections and Investigations | |
| June 7, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shenzhen Creative Industry Co., Ltd.
- FDA Inspection 1082638 - 2018-11-08
- FDA Inspection 790430 - 2012-06-07
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