1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Optimi Labs Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
3Laboratory and QC controls
The validation of test methods was inadequate.
4Training and personnel
The ongoing training of personnel was inadequate.
5Validation and qualification
Validation studies were not conducted in keeping with the predefined protocols. The master production documents were inadequate.
6Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-15. 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.
