2179267 Ontario Ltd. O/A Britman Packaging Services — Health Canada Inspection Findings

The quality control department's handling of complaints and/or information received about drug quality was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.

The training, experience, and/or delegated duties for the individual responsible for labelling operations and/or the quality control department of a secondary labeller were inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The implementation of a self-inspection program was inadequate. The written procedures for recalls were inadequate.

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

The control of quarantine areas was inadequate. The temperature and/or humidity control was inadequate.

The preventative maintenance and repair of the equipment was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.