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1170460

Dr. Reddy's Laboratories, Inc. — FEI 3003989912

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Princeton, NJ (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Facility

Other inspections at this facility

  • 1119494 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858994 (NAI Mon Dec 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725605 (VAI Mon May 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
21352FDCA 505-1(e)(2)(A)Failure to comply with REMS Medication Guide
21353FDCA 505-1(e)(3)Failure to comply with REMS Communication Plan