Inspection Record

Linhai Huanan Chemical Co., Ltd. — Health Canada Inspection Findings

Health CanadaInspected 2024-07-15 5 findingsQuality unit oversightDeviation, CAPA, and investigationOther quality systemComputer system validation

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

Findings

1Quality unit oversight

The annual product quality review procedure was inadequate.

2Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

3Other quality system

The master formulas to control the manufacturing process were inadequate.

4Computer system validation

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

5Other quality system

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

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-07-15. 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.

Linhai Huanan Chemical Co., Ltd. company profile — full history Health Canada documents, 2024 Go to Findings search