1Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
Inspection Record
PCI Pharma Services Canada, Inc. — 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 recorded information or details were inadequate. The maintenance of records of complaints about the quality of a drug was inadequate.
3Computer system validation
Measuring devices were not regularly checked for accuracy and precision. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-25. 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.
