1Other quality system
The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
Inspection Record
GenMed, a division of Pfizer Canada ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
3Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
4Stability 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-08-07. 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.
