Neopharm Laval — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The company's monitoring and documentation of moist heat sterilization cycles was inadequate.

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

The validation and/or the documentation of test methods was inadequate.

The monitoring procedures for microbial and/or environmental conditions were inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The receipt, preparation, and/or handling of reagents and culture media was inadequate. The suitability of the culture media was not verified. The expiry date of the prepared culture media was not supported by the growth-promotion testing.