Non-compliance, Corrective Actions and Recall

In the event of non-compliance, authorities may order corrective measures, such as suspending the provision of products in the market, mandatory rectification, withdrawal from distribution channels, or a recall from end-users. Corporations are obligated to identify the root causes, implement corrective actions, trace affected batches, and adequately inform both authorities and customers.

Practice: A centralised incident and CAPA process complete with defined roles, deadlines, and templates for communication and documentation accelerates execution. Recall checklists, serial / batch traceability, and pre-approved press release drafts mitigate reputational and liability risks.