Lernapharm (Loris) Inc. — Health Canada Inspection Findings

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

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 design, construction, and/or location of the equipment did not allow adequate cleaning, sanitizing, and/or inspection of the equipment.

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

The annual product quality review procedure was inadequate.

The protection of products and/or materials from contamination was inadequate.

The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator 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.

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

The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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.