943992

Hologic, Inc. — FEI 2024800

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
San Diego, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation