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632946

Repro Lab, Inc. — FEI 3000974212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1255573 (VAI Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172852 (NAI Fri Jun 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131538 (VAI Fri Oct 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045046 (VAI Mon Mar 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961911 (VAI Tue Mar 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1223021 CFR 1271.50(a)Responsible person to determine, document
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1227921 CFR 1271.75(b)Risk factors, leukocyte-rich cells or tissues
1228321 CFR 1271.75(e)Abbreviated procedure
1228621 CFR 1271.80(b)Specimen collections not timely