1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Delta Pharma 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 guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
3Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
4Equipment and facility
The maintenance of the premises was inadequate.
5Equipment and facility
The maintenance of records was inadequate.
6Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
7Equipment and facility
The preventative maintenance and repair of the equipment was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
8Other quality system
The master formulas to control the manufacturing process were inadequate.
9Equipment 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.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Material and supplier control
The handling of rejected materials and products was inadequate. The recorded information or details were inadequate.
12Other quality system
The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-03. 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.
