1Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
Inspection Record
Chief Medical Supplies 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 implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
3Laboratory and QC controls
The quality control department did not undertake all of the required activities. The validation and/or the documentation of test methods was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Training and personnel
The ongoing training of personnel was inadequate. The effectiveness of the training was not assessed by the firm.
7Other quality system
The company's monitoring of water testing was inadequate.
8Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Material and supplier control
A sample from each lot of raw materials was not fully tested against the specifications.
10Laboratory and QC controls
The quality control department did not undertake all of the required activities.
11Equipment and facility
The maintenance of the premises was inadequate.
12Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
13Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-04-28. 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.
