What happens if inspectors identify some minor defects during an on-site inspection?

If a pharmacist inspector identifies “minor defects” during an on-site inspection, this will not usually lead to your application being refused outright. Minor defects are small issues that do not directly affect medicine safety or quality and can be corrected promptly. Examples include failing to update a cleaning record for one area, a minor formatting error in a non-core SOP, or an unclear label on a shelf. In such cases, the inspector will usually point out the issues orally at the end of the inspection or in a subsequent inspection report. You must complete the corrective actions within the specified period (for example, one to two weeks) and respond to the Department of Health in writing with evidence that the actions have been completed, such as photographs or updated documents. Provided that you complete the corrective actions promptly and effectively, these minor defects will generally not affect the PPB’s positive assessment of your application.