Eurofins CDMO Alphora Incorporated — Health Canada Inspection Findings

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were 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 usage logs for the equipment used for significant processing and/or testing operations were inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.

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

The design, equipment, and/or maintenance of the testing laboratory was inadequate.