Medreich Ltd. — Health Canada Inspection Findings

The ongoing training of personnel was inadequate.

The implementation of a self-inspection program was inadequate.

The master production documents were inadequate. The recorded information or details were inadequate.

The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

Measures to ensure the compliance of the contracted test laboratories were inadequate.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.

The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.

The availability, implementation, and/or quality of the written sanitation program was inadequate.