1Complaint and recall handling
The written procedures for recalls were inadequate.
Inspection Record
Produits Chimiques Regent Ltee — 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 calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. Measuring devices were not regularly checked for accuracy and precision. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
4Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.
5Laboratory and QC controls
The quality control department did not release the materials that were used.
6Other quality system
Lots or batches of finished product did not comply with the specifications and were made available for further fabrication or sale.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
9Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
10Equipment 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.
11Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. 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 2022-12-12. 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.
