1Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
Inspection Record
Vita Bee Health Canada Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written procedures for recalls were inadequate.
3Other quality system
The written self-inspection procedure was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Validation and qualification
Validation studies were not conducted in keeping with the predefined protocols.
7Equipment and facility
The maintenance of records was inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-26. 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.
