1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.
Inspection Record
Medicine Place Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
4Labeling 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). The handling of standard operating procedures for good manufacturing practices was inadequate.
5Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Other quality system
The written procedures and records for retaining samples were inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
9Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
10Complaint and recall handling
The written procedures for recalls were inadequate.
11Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
12Laboratory and QC controls
The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-28. 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.
