Morton Grove Pharmaceuticals, Inc. — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has b1!en already distributed.

The written stability testing program is not followed.

Time limits are not established when appropriate for the completion ofeach production phase to assure the quality of the drug product.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, drug product containers, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity.

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

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

Laboratory records do not include a complete record of all data secured in the course ofeach test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, lot tested, and drug product tested.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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

Production personnel were not practicing good sanitation and health habits.