Novartis Consumer Health — FDA 483 Findings

Investigations of an enexplained 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.

GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

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

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

Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.