1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Eurofins Biopharma Product Testing Toronto 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.
3Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Aseptic processing and sterility assurance
The operators' aseptic practices were inadequate to maintain sterility.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
8Laboratory and QC controls
The validation of test methods was inadequate. The written protocol and/or the assessment of the test method transfer was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-22. 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.
