1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Perfomics Analytical Labs LLP — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The expiry date of the prepared culture media was not supported by the growth-promotion testing.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Stability and storage
The temperature and/or humidity control was inadequate.
5Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
6Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
7Training and personnel
The ongoing training of personnel was inadequate.
8Laboratory and QC controls
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-06-09. 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.
