1Stability and storage
For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.
Inspection Record
TJP Labs 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 guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
3Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Equipment and facility
The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-04-27. 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.
