Brenntag Canada Inc. — Health Canada Inspection Findings

The ongoing stability program for a drug was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The quality control department did not undertake all of the required activities. The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.

The computerized system used to manage product inventory and distribution records to support recalls was not validated.

The assessment to release finished products was inadequate.

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.