FDA Spells out How Firms Should Be 'Recall Ready'
Executive Summary
Draft guidance outlines how manufacturers and distribution partners should prepare for, plan and conduct voluntary recalls of drugs and other FDA-regulated products.
You may also be interested in...
The Quality Lowdown: DSCSA, Recalls, Extractables & Leachables And Nitrosamines
The US FDA refines guidance on verification systems for suspect drug products and voluntary recalls, while industry groups issue guidance on extractables and leachables in parenteral drugs and the role of excipients in nitrosamine formation.
Recall-Related Public Warnings Get Final US FDA Guidance
There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.
The Quality Lowdown: FDA's Enhanced Drug Recall Authority
Opioid crisis gives US FDA something heparin crisis couldn’t: more drug recall authority in some cases. Meanwhile, Hanlim warning letter and Mercury Labs and Recipharm EU GMP non-compliance statements prove illuminating.