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Lupin, the pharma major, has received six US FDA Form 483 observations for its Indore plant.
The regulator has said that the observations included no thorough review of any unexplained discrepancy and there were “no conclusions in written records of probes into unexplained discrepancies.”
It further said that there were no follow ups in written records of probes into the unexplained discrepancies.
The regulator also highlighted the absence of written procedures for production and process controls at the Indore facility and noted that “batch production and control records were deficient.”
The pharma major has said that it is responding to the observations.
