FDA Inspection
SHENZHEN YUEZHONGXING TECHNOLOGY CO LTDSHENZHEN YUEZHONGXING TECHNOLOGY CO LTD – FDA Inspection, Jul 31, 2025
Record Details
This FDA Inspection record concerns SHENZHEN YUEZHONGXING TECHNOLOGY CO LTD, with an inspection on July 31, 2025, covering medical devices & rad health.
- Inspection Date
- July 31, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · b5b809cb-a304-4057-8095-c213341a8b67
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1278398
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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