1Stability 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.
Inspection Record
Teva Women's Health, LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Contamination control
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. Measuring devices were not regularly checked for accuracy and precision.
5Complaint and recall handling
Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
6Documentation and records
Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
7Other quality system
The assessment to release finished products was inadequate.
8Material and supplier control
The identity testing of primary packaging materials once they were received on the premises by a person that packages the drugs was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-02-23. 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.
