FDA Inspection
Hong Qiangxing (Shen Zhen) Electronics LimitedHong Qiangxing (Shen Zhen) Electronics Limited – FDA Inspection, Aug 7, 2025
Record Details
This FDA Inspection record concerns Hong Qiangxing (Shen Zhen) Electronics Limited, with an inspection on August 7, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 7, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8c14bf74-7d85-48bb-9e5e-2480eb6462ee
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1271550
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Hong Qiangxing (Shen Zhen) Electronics Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hong Qiangxing (Shen Zhen) Electronics Limited
- FDA Inspection 976602 - 2016-07-14
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