Pfizer Canada ULC — Health Canada Inspection Findings

The quality control department's handling of complaints and/or information received about drug quality was inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range. 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 evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.

The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.