1Other quality system
The written specifications were inadequate.
Inspection Record
Novel Biome Solutions Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
3Equipment and facility
The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
4Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale. For a drug that requires additional preparation before use, stability data was not available for the ready to use drug preparation.
5Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-13. 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.
