1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Contract Pharmaceuticals Limited Canada — 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 quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
3Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
4Deviation, CAPA, and investigation
The deviation investigations to reconcile bulk product or printed packaging materials were inadequate.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
10Other 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 2021-03-04. 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.
