FDA Final Guidance on Recalls

The FDA published the final guidance for “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” in March of 2022.

Nothing new here really, as the FDA has just finalized recommendations that companies make adequate preparations to operations in advance of when a recall may be needed (e.g., prepare and execute a recall communications plan). In addition to these preparations, the FDA recommends that companies consider preparing, maintaining, and documenting written procedures (in paper or electronic format) for initiating a recall and performing actions related to initiating a recall. Moreover, the document addresses how companies should develop a recall strategy and train personnel on executing a recall, as well as how companies should use adequate product coding.

Similac Recall is a Systematic Failure in our Food/Drug Safety

There has been a lot of press lately for the Abbott Nutrition recall of infant formula. Fundamentally this is a colossal failure of our regulatory program, another failure in a long string of failures, and confirmation that the time is now for radical changes in the agency.

Consumer Reports, in the article “How the FDA Bungled the Powdered Infant Formula Recall” does a good job covering the important points, so please read that article.

The optimist in me hopes that this calamity will drive needed change, as has been the unfortunate history of regulatory change in this country. I’m just not sure I hold enough confidence in Congress to get the job done.

GMP mistakes are costly

In the continual saga of companies making fundamental GMP mistakes, Gilead has recalled two lots of its coronavirus treatment drug Remdesivir because of the “presence of glass particulates.”

If only there existed international standards on visual inspection and there were a solid set of best practices on lyophilization.

Oh, wait there are.

But then Gilead has a multi-year track record in deficiencies in their testing and manufacturing processes. In all fairness, they are contracting manufacturing to Pfizer’s McPherson site…..oh wait that site got an FDA 483 in 2018 specifying significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.

We deserve better manufacturers. Companies need to take the quality of their products seriously. We are always improving or we are always one step away from the sort of press Gilead gets.