Company
ChinaHong Qiangxing (Shen Zhen) Electronics Limited, Shenzhen, China – FDA Inspections
Inspection records and compliance data for Hong Qiangxing (Shen Zhen) Electronics Limited in Shenzhen. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected August 07, 2025.
Company Profile
This profile covers Hong Qiangxing (Shen Zhen) Electronics Limited based in Shenzhen, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected July 14, 2016. Last inspected August 7, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1271550 |
| July 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 976602 |
FDA documents
Warning Letters (1)
People (1)
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Company Information
Name
Hong Qiangxing (Shen Zhen) Electronics Limited
FEI Number
3010402752
Address
Jingcheng Building F 4, Xixiang Street; Baoan, Shenzhen, China
Country
China
ID: 9fb4b9a4-79b9-46c7-b4e1-9b9b02d321fc