Lupin Limited — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Established laboratory control mechanisms are not documented at the time of performance.

Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.