GE Healthcare Canada Inc. — Health Canada Inspection Findings

Documents were not available on the premises. The recorded information or details were inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

The assessment to release finished products was inadequate.

The ongoing stability program for a drug was inadequate. The frequency of stability testing of a drug did not comply with the marketing authorization.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

Test methods were not validated or the method transfer studies were not conducted. The written specifications were inadequate.

The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.