1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Apotex Research Private 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.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Other quality system
The master formulas to control the manufacturing process were inadequate. The master production documents were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-10. 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.
