1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Generic Medical Partners Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
5Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
6Other quality system
The assessment to release finished products was inadequate.
7Stability and storage
The ongoing stability program for a drug was inadequate.
8Other quality system
The implementation of a self-inspection program was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-08. 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.
