1Other quality system
The electronic system was not validated for its intended use.
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 monitoring procedures for microbial and/or environmental conditions were inadequate. The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Equipment 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.
5Stability 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. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Equipment and facility
The design of the drug stability study was inadequate and/or not justified with a documented rationale. "The maintenance of records was inadequate.
8Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.
9Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.
10Material and supplier control
The protection of products and/or materials from contamination was inadequate.
11Material and supplier control
The written procedures and records for retaining samples were inadequate. The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions.
12Equipment and facility
A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
13Complaint and recall handling
The written procedures for recalls were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-12-11. 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.
