1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Biocon Limited — 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.
3Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
9Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-12. 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.
