1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Andone Pharmaceutical Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The written self-inspection procedure was inadequate.
3Equipment 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.
4Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
5Complaint and recall handling
The written procedures for recalls were inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
8Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
9Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
10Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-18. 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.
