1Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
Inspection Record
Sterinova Inc — 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. The written clothing standards for each environmental grade were inadequate. The operators'aseptic practices were inadequate to maintain sterility.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
7Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
8Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
9Material and supplier control
Precautions were not taken to ensure that containers were free from contamination by foreign material.
10Material and supplier control
Printed packaging materials were not stored in an area with restricted access.
11Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-11. 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.
