IMCD Canada Limited — Health Canada Inspection Findings

The maintenance of records was inadequate.

The ongoing stability program for a drug was inadequate.

The recorded information or details were inadequate.

The temperature and/or humidity control was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. Periodic confirmatory testing was not conducted. The evidence required to demonstrate compliance with finished product specifications was inadequate.

The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.

The assessment to release finished products was inadequate. The company did not retain a sample of each lot or batch of a drug, raw material, and/or an active ingredient.

The master production documents were inadequate.