Y.S.P. Industries (M) Sdn. Bhd. — Health Canada Inspection Findings

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The maintenance of the premises was inadequate.

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

The implementation of minimum health and hygiene requirements for personnel was inadequate for ensuring the clean and sanitary fabrication, packaging, and/or labelling of drugs.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate. The quality control department did not undertake all of the required activities.

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

The maintenance of records was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.