1Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
Inspection Record
The Avon Company Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Laboratory 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. The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
4Complaint and recall handling
The written procedures for recalls were inadequate.
5Other quality system
The written specifications were inadequate.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend . The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
8Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
9Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
10Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The recorded information or details were inadequate.
11Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
12Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
13Stability 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. The temperature and/or humidity control was inadequate.
14Other quality system
The implementation of a self-inspection program was inadequate.
15Equipment and facility
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
16Material and supplier control
The written specifications were inadequate. The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
17Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
18Other quality system
The controls put in place for electronic signatures were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-15. 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.
