Inspection Record

Agrisan Specialty Chemical & Pharmaceutical a division of Agrisan Inc. — Health Canada Inspection Findings

Health CanadaInspected 2025-09-15 11 findingsCleaning validationLaboratory and QC controlsEquipment and facilityContamination controlDeviation, CAPA, and investigationMaterial and supplier controlOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Cleaning validation

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

2Laboratory and QC controls

The sampling plan for packaging materials was inadequate. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.

3Equipment and facility

The preventative maintenance and repair of the equipment was inadequate.

4Laboratory and QC controls

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

5Equipment and facility

Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate.

6Contamination control

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

7Equipment and facility

The maintenance of records was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

8Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate.

9Material and supplier control

The handling of rejected materials and products was inadequate.

10Other quality system

The assessment to release finished products was inadequate.

11Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The establishment and/or the maintenance of a data governance plan 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.

Other records for this company

Agrisan Specialty Chemical & Pharmaceutical a division of Agrisan Inc. company profile — full history Health Canada documents, 2025 Go to Findings search