Principle
- All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures. In order to provide for all contingencies, a system should be designed to promptly and effectively recall products known or suspected to be defective, from the market.
Complaints
- There should be a procedure established, implemented and maintained for the investigation of adverse events and product complaints.
Recalls
- A written procedure for product recall should be established, implemented and maintained. The procedure should specify the actions to be taken for all reasonable contingencies that may be anticipated. It should be capable of being put into operation at any time, and should include emergency and 'out of hours' contacts and telephone numbers. Distribution records should be maintained, to expedite the recall of any product or material whenever necessary.
- The national therapeutic goods regulatory authority should be informed promptly if products are intended to be recalled because they are, or are suspected of being defective.
- The recall of a product should be followed immediately by an investigation of the reasons for the recall. The record of the recall should include all action taken from initial advice to final closeout.