1Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
Inspection Record
Searchlight Pharma 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 investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate. The assessment of the contractor's competencies by the fabricator, packager/labeller, distributor, or importer was inadequate.
5Validation and qualification
The consultants and/or contractors did not have the necessary qualifications, training, and/or experience.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Stability and storage
The ongoing stability program for a drug was inadequate.
8Other quality system
Complete testing was not performed according to the requirements. The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-10-10. 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.
