1271550

Hong Qiangxing (Shen Zhen) Electronics Limited — FEI 3010402752

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 7, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Baoan District (China)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367721 CFR 820.30(g)Design validation - software validation not performed
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures