1Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
Inspection Record
Merck Sharp & Dohme LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written procedures for recalls were inadequate.
3Other quality system
Documents were not available on the premises.
4Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
5Material and supplier control
The sampling plan for raw materials was inadequate.
6Cleaning validation
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
7Other quality system
Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-05. 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.
