Dalton Chemical Laboratories Inc. O/A Dalton Pharma Services — Health Canada Inspection Findings

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The company's monitoring and documentation of heat sterilization cycles was inadequate.

The validation of aseptic processing was inadequate.

The drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination. The areas where raw materials and/or drugs were exposed to an increased risk of contamination were inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate.

The operators'aseptic practices were inadequate to maintain sterility. There was excessive movement of personnel in the clean areas especially during aseptic operations. The condition of the clean area used to produce sterile products was inadequate. The process to transfer materials in and out of the isolator was inadequate.

The company's visual inspection of filled containers was inadequate.

The testing of the isolator and the glove or sleeve system for leaks was inadequate. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.

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

Evaluation of production processes, equipment, and/or materials was inadequate.

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

The samples taken for sterility testing were not representative of the whole batch.

The process was inadequate for the environmental classification of aseptic or clean areas. The number of samples taken for environmental monitoring was insufficient. The company did not monitor the aseptic filling area frequently enough to avoid possible contamination or system deterioration.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The electronic system was not validated for its intended use.

The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products.

The documentation for the integrity testing of sterilizing filters was inadequate.

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.