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1045046

Repro Lab, Inc. — FEI 3000974212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2018
Fiscal Year
2018
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))
  • 961911 (VAI Tue Mar 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895463 (VAI Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223021 CFR 1271.50(a)Responsible person to determine, document
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence