Inspection Record

Steriscience Specialties Private Limited — Health Canada Inspection Findings

Health CanadaInspected 2024-09-14 3 findingsAseptic processing and sterility assuranceOther quality systemEquipment and facility

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

Findings

1Aseptic processing and sterility assurance

The condition of the clean area used to produce sterile products was inadequate. The company's cleaning of the premises and the equipment in aseptic areas was inadequate. There was excessive movement of personnel in the clean areas especially during aseptic operations.

2Other quality system

The recorded information or details were inadequate.

3Equipment and facility

Evaluation of production processes, equipment, and/or materials was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-09-14. 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.

Steriscience Specialties Private Limited company profile — full history Health Canada documents, 2024 Go to Findings search