1Other quality system
The electronic system was not validated for its intended use.
Inspection Record
Ccrest 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 receipt, preparation, and/or handling of reagents and culture media was inadequate.
3Computer system validation
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
7Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
9Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
10Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-07. 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.
