Sandoz, Inc. — FDA 483 Findings

Control procedures are not established which vaiidate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and inaintenance.

The quality control unit lacks authority to fully investigate errors that have occurred.

Established laboratory control mechanisms are not followed.

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

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.

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

Deviations from written laboratory mechanisms are not recorded.

Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.

Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.