1Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
Inspection Record
Lyophilization Services of New England Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Aseptic processing and sterility assurance
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
4Deviation, CAPA, and investigation
The company's investigations of microbial contamination in critical areas were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-21. 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.
