1Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
Inspection Record
Seaford Pharmaceuticals 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.
3Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
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.
6Other quality system
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.
7Stability and storage
The ongoing stability program for a drug was inadequate.
8Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-18. 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.
