1Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
Inspection Record
Agrisan Specialty Chemical & Pharmaceutical a division of Agrisan Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Material and supplier control
The protection of products and/or materials from contamination was inadequate.
9Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
10Material and supplier control
The identification, quarantine, and/or disposal of rejected materials was inadequate.
11Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-23. 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.
