Dr. Reddy's Laboratories Limited — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed { | Specifically, your Quality Unit failed to conduct a comprehensive evaluation and implement appropriate and | effective corrective and preventive actions to prevent reoccurrence of aborted HPLC sequence events.

Employees engaged in the manufacture and processing of drug product lack the training and experience to perform | their assigned functions.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions E YEE(S)

Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product that may have been associated with the specific failure or discrepancy.

The batch production and control records are deficient in that they do not include identification of persons performing each significant step in the operation.