1Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
Inspection Record
Dalton Chemical Laboratories Inc. O/A Dalton Pharma Services — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
3Aseptic processing and sterility assurance
The company did not monitor the steam used for sterilization for suitable quality.
4Other quality system
The suitability of the culture media was not verified.
5Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
6Other quality system
The company's visual inspection of filled containers was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Other quality system
The master production documents were inadequate.
9Aseptic processing and sterility assurance
The company did not justify the hold time for sterilized components, containers, or equipment.
10Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
11Environmental monitoring
The number of samples taken for environmental monitoring was insufficient. The environmental sampling methods were inadequate.
12Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
13Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
14Cleaning validation
The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-10-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
