Novartis Consumer Health, — FDA 483 Findings

Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy, and explaining the reasons for the failure of the batch or any of its components to meet specifications.

C) DEPARTMENT OF IIEALTH ANO IIUMAN SEitviCES FOOD AND ORIJG A0.'-11NISTRATION l!.lf£1SIOFlloiSPEC1 ~ -OiSffOICf AOCAUSNCI't<()!.E HUMif.ll 06/13/2011 - 07/08 / 2011* 11630 W.

GMP training is not conducted with sufficient frequency to assure that employees remain famil iar with CGMP requirements a pplicable to them.

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 batch records do not record the distinctive identification number, code, and name of equipment to identify majo r equipment to show the specific equipment used in the manufacture of a batch of a drug product.

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

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.

Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.

The responsibilities and procedures applicable to the quality control unit are not fully followed: Specifically, 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.

Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.

The number of qualified personnel is inadequate to perform and supervise the m anufacture, processing, packing, and holding of each drug product.

An NDA-Field Alert Re port was not submitted wi thin three working days of receipt of information concerning an incident tha t caused a drug product or its labeling to be mistaken for another article.

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

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