1Aseptic processing and sterility assurance
The validation of aseptic processing 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
2Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
3Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
4Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
5Other quality system
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.
6Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
7Other quality system
The company's visual inspection of filled containers was inadequate.
8Complaint and recall handling
The written procedures for recalls were inadequate.
9Laboratory and QC controls
Precautions were not taken to ensure that containers were free from contamination by foreign material. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.
10Equipment 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. Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-27. 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.
