1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Zhejiang Lepu Pharmaceutical Co., Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The master production documents were inadequate.
3Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-08. 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.
