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1172852

Repro Lab, Inc. — FEI 3000974212

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 24, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
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))
  • 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))
  • 895463 (VAI Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1225521 CFR 1271.60(c)Shipped but not kept in quarantine
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence