1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
Inspection Record
Aktinos Pharma Pvt Limited — 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 quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
3Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The labelling of outlets for liquids and/or gases was inadequate.
4Material and supplier control
The identity testing of primary packaging materials once they were received on the premises by a person that packages the drugs was inadequate.
5Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
6Equipment 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.
7Stability and storage
The temperature and/or humidity control was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-09-09. 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.
