Novartis Consumer Health — FDA 483 Findings

There is no written testing program designed to assess the stability characieristics of drug products.

Deviations from written production and process control procedures are not justified.

The responsibilities and procedures applicable to rhe quality control unit are not fully followed Speci.fi.cally, Your Quality Unit has failed in the responsibility and authority to monitor Quality systems designed to assure the quality of drug products manufactured and packaged at your firm.

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can c ause deterioration or contamination of the drug product .

Written records of investigations into unexplained discrpancies do not always include the conclusions and follow-up.

Procedures describing the handling of written and oral complaints related to drug products are not written or followed.

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Written procedures are not followed for evaluations CQnducted at least annually to review rec.ords associated with a r epresentative number of batches, whether approved or rejected.

Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.