1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
Inspection Record
Eurofins CDMO Alphora Incorporated — 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 controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
6Other quality system
The recorded information or details were inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-11. 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.
