Sun Pharmaceutical Industries Ltd. — FDA 483 Findings

Laborato1y controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.

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

Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation of the aseptic process.

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

Procedures designed to prevent microbiological contamination of mu g products pmpo1ting to be sterile are not established and followed.

Your fom failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess.

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

Batch production and control records do not include complete info1mation relating to the production and control ofeach batch.