Inspection Record

Allerquest LLC — Health Canada Inspection Findings

Health CanadaInspected 2023-08-07 7 findingsDeviation, CAPA, and investigationComplaint and recall handlingCleaning validationOther quality systemLaboratory and QC controls

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

Findings

1Deviation, CAPA, and investigation

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

2Complaint and recall handling

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

3Cleaning validation

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

4Deviation, CAPA, and investigation

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

5Other quality system

The airborne particle monitoring system was inadequate.

6Laboratory and QC controls

The quality control department did not undertake all of the required activities.

7Other quality system

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-08-07. 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.

Allerquest LLC company profile — full history Health Canada documents, 2023 Go to Findings search