Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA. vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions. viii Reason / Issue: Reason for the recall action. ix Recall Action: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues o ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...