1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
The Fertility Partners Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
There was no evidence of a functioning and/or independent quality control department. There was no person on site and/or fully available to the quality control department who was responsible for making decisions for the quality control requirements.
3Other quality system
The written self-inspection procedure was inadequate. The implementation of a self-inspection program was inadequate.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-28. 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.
