Inspection Record

Lernapharm (Loris) Inc. — Health Canada Inspection Findings

Health CanadaInspected 2024-10-22 6 findingsOther quality systemComplaint and recall handlingMaterial and supplier controlEquipment and facilityLaboratory and QC controls

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

Findings

1Other quality system

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

2Complaint and recall handling

The written procedures for recalls were inadequate.

3Other quality system

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

4Material and supplier control

The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate. The protection of products and/or materials from contamination was inadequate.

5Equipment and facility

Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.

6Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-10-22. 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.

Other records for this company

Lernapharm (Loris) Inc. company profile — full history Health Canada documents, 2024 Go to Findings search