1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Ind-Swift Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
5Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Other quality system
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-06. 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.
