1Other quality system
The suitability of the culture media was not verified.
Inspection Record
Smithfield Bioscience, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The recorded information or details were inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
The shelf life of a drug was not based on the date of fabrication and/or the market authorization.
6Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
7Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
8Equipment and facility
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.
9Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
10Stability and storage
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-15. 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.
