1Other quality system
The company's visual inspection of filled containers 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
2Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Aseptic processing and sterility assurance
Evaluation of production processes, equipment, and/or materials was inadequate. The company did not adequately validate how the sterilizer was loaded. The company's monitoring and documentation of heat sterilization cycles was inadequate. The validation of aseptic processing was inadequate. The company's validation of sterilization with ethylene oxide was inadequate. The company did not verify the sterilization process at scheduled intervals or after significant modifications.
7Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
8Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
9Aseptic processing and sterility assurance
The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-20. 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.
