Aurobindo Pharma Limited Unit 16 — FDA 483 Findings

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

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

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

The accuracy, sensitivity and specificity of test methods have not been documented.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Written procedures are lacking which describe in sufficient detail the sampling and testing of components.

The records for components do not include the identity and quantity of each shipment of each lot, name of the supplier, supplier's lot number and date of receipt.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

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.