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1256275

ADMA Biologics, Inc — FEI 1000525461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2024
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Boca Raton, FL (United States)

Facility

Other inspections at this facility

  • 1219342 (NAI Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150114 (VAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049629 (VAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974061 (OAI Thu Mar 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892829 (OAI Thu Aug 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures