1Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
Inspection Record
Syndel Laboratories Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-07. 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.
