Home / Inspections / 728334

728334

Westchester Medical Center Pathology Department — FEI 3005888575

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 20, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Valhalla, NY (United States)

Facility

Other inspections at this facility

  • 1255924 (NAI Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175324 (NAI Fri Jul 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086871 (NAI Wed Jan 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1236921 CFR 1271.200(b)Procedures inadequate
1237521 CFR 1271.210(a)Use prior to verification
1238121 CFR 1271.210(d)(2)Verification elements
1239821 CFR 1271.230(a)Validation & approval--established procedures
1239921 CFR 1271.230(a)Process validation procedures
1243721 CFR 1271.270(a)Records incomplete