1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
LEC Custom Products Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
4Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
5Equipment 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.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
9Complaint and recall handling
The written procedures for recalls were inadequate.
10Laboratory and QC controls
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 quality control department did not undertake all of the required activities.
11Material and supplier control
The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.
12Cleaning validation
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
13Other quality system
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
14Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
15Other quality system
The written specifications were inadequate. The availability or the content of the authentic certificate of analysis was inadequate. Lots or batches of finished product were not examined or tested against the specifications before they were fabricated or sold.
16Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate.
17Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-07-31. 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.
