Natco Pharma 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 records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

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

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

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

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 drug product.

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.

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