Sun Pharmaceutical Industries Limited — FDA 483 Findings

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

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the dmg product.

Procedures describing the handling of written and oral complaints related to diug products are deficiently written or followed.

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

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

An tt>ll4) -Field Alert Repo1t was not subinitted within three working days of receipt of info1mation concerning significant chemical, physical, or other change or deterioration in a distributed dmg product.