1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
Inspection Record
Lonza Biologics Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media. The receipt, preparation, and/or handling of reagents and culture media was inadequate.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Training and personnel
The ongoing training of personnel was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Material and supplier control
The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.
8Material and supplier control
Precautions were not taken to ensure that containers were free from contamination by foreign material.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-01-11. 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.
