Wanbury receives EIR from FDA for Patalganga facility
Drug Approval

Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation

  • By IPP Bureau | August 23, 2024

Wanbury has announced that the USFDA has issued an Establishment Inspection Report ("EIR") for the Company's manufacturing facility located at MIDC Industrial Area, Patalganga, Maharashtra, India and the inspection has now been successfully closed by the USFDA.

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation.

Based on this inspection, this facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).

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