BLES Biochemicals Inc — Health Canada Inspection Findings

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

The controls put in place for electronic signatures were inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

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

The ongoing training of personnel was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

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

Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.

The operators'aseptic practices were inadequate to maintain sterility. The company did not adequately protect sterilized material to prevent re-contamination after sterilization.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of records was inadequate.

The written self-inspection procedure was inadequate. The implementation of a self-inspection program was inadequate.

The temperature and/or humidity control was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.