1Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
Inspection Record
Eisai Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
3Other quality system
Periodic confirmatory testing was not conducted.
4Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
7Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
8Other quality system
The assessment to release finished products was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Stability and storage
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-29. 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.
