1Material and supplier control
The drug fabricator's specifications for raw materials were inadequate. The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
Inspection Record
Laboratoire Lalco 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 establishment of specifications was inadequate for packaging materials approved by the quality control department.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Other quality system
The electronic system was not validated for its intended use.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
The written procedures and records for retaining samples were inadequate.
7Laboratory and QC controls
There was no person on site and/or fully available to the quality control department who was responsible for making decisions for the quality control requirements. Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position.
8Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
9Laboratory and QC controls
The product was made available for sale without the approval of the quality control department. The assessment to release finished products was inadequate. The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.
10Quality unit oversight
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented. The quality control department did not evaluate the results of the annual product quality review.
11Complaint and recall handling
The written procedures for recalls were inadequate.
12Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-03. 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.
