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.

Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.

Records are not kept for the cleaning and sanitizing of equipment.

Written procedures are not followed for the storage and handling of components.

Input to and output from the computer, related systems of formulas, and records or data are not checked for accuracy.

Drug products failing to meet established specifications and quality control criteria are not rejected.

Reserve samples from representative sample lots or batches ofdrug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

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.