1Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
Inspection Record
10445517 Canada Inc / North Pharmaceuticals / DAC Pharmaceuticals — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures. Documents were not available on the premises.
4Equipment and facility
The design of the drug stability study was inadequate and/or not justified with a documented rationale. The ongoing stability program for a drug was inadequate. "The maintenance of records was inadequate.
5Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-22. 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.
