1Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
Inspection Record
Galentic Pharma India Pvt, Ltd — 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 operators'aseptic practices were inadequate to maintain sterility.
3Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
4Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
5Other quality system
The company's visual inspection of filled containers was inadequate.
6Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
7Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
8Aseptic processing and sterility assurance
The written sanitation program for clean areas was inadequate. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
9Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-05-25. 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.
