Apotex Inc. — 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.

Written procedures are not established that describe the tests and exaininations to be conducted on appropriate samples of in-process materials of each batch.

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.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

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 diug product.

Your fnm 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 ai·e purpoited or represented to possess.

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

Established sampling plans and test procedures are not followed and documented at the time of perfo1mance.

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

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