1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
Delpharm Boucherville Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
3Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
6Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas. The qualification and/or verification of utilities and/or support systems was inadequate.
7Labeling and packaging
The training, experience, and/or reporting structure of the individual responsible for packaging operations was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
8Material and supplier control
The sampling plan for raw materials was inadequate.
9Cleaning validation
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.
10Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. Evaluation of production processes, equipment, and/or materials was inadequate.
11Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
12Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate. The samples taken for sterility testing were not representative of the whole batch.
13Other quality system
The company's visual inspection of filled containers was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-09. 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.
