1Other quality system
The assessment of the contractor's competencies by the fabricator, packager/labeller, distributor, or importer was inadequate.
Inspection Record
Faculty of Pharmacy and Pharmaceutical Sciences — 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 validation and/or the documentation of test methods was inadequate.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Validation and qualification
Validation studies were not conducted in keeping with the predefined protocols.
7Equipment and facility
Validation studies were not conducted in keeping with the predefined protocols. The validation of equipment or the planned maintenance of equipment was inadequate.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
9Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
10Laboratory and QC controls
The specifications approved by the quality control department were not available for all raw materials used to produce drugs.
11Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
12Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
13Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
14Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
15Laboratory and QC controls
The quality control department did not undertake all of the required activities.
16Other quality system
A document was not issued for each vendor verifying the vendor meets the criteria for certification.
17Other quality system
The master production documents were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-05. 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.
