1Stability 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.
Inspection Record
Cosmetica Laboratories Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The controls put in place for electronic signatures were inadequate.
5Equipment and facility
"The maintenance of records was inadequate. The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-01. 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.
