1283682

Diversified Healthcare Development LLC — FEI 3001541016

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Independence, VA (United States)

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
367721 CFR 820.30(g)Design validation - software validation not performed
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements