Sandoz, Inc. — FDA 483 Findings

Specifically, your multipoint content uniformity acceptance criteria is not adequate to assure that batches of drug products meet each appropriate specifiation and appropriate statistical quality control criteria as a condition for their approval and release.

Established test procedures are not followed.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure com pliance with established specifications and standards.

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

Examination and testing of samples is not doe to assure that in-process materials conform to specifications.

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

i• There is a failure to supply potable water under continuous positive pressure.