1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Eurofins BioPharma Product Testing India Private Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
3Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
4Stability and storage
The temperature and/or humidity control was inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
7Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
8Laboratory and QC controls
The handling of standard operating procedures for good manufacturing practices was inadequate. The validation and/or the documentation of test methods was inadequate.
9Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
10Aseptic processing and sterility assurance
Personnel without appropriate training, qualifications, or successful participation in a process simulation study, performed aseptic processing.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-06-03. 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.
