1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
Inspection Record
Neopharm Labs Inc. — 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 education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
3Equipment and facility
The maintenance of detailed plans or specifications was inadequate for each building where drugs are fabricated, packaged, labelled, and/or tested.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-12-09. 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.
