Post by Dave Schoneker

FDA SENDS A MESSAGE REGARDING THEIR EXPECTATIONS FOR RAW MATERIAL TESTING (INCLUDING EXCIPIENTS), PROPER USE OF COA DATA IN REDUCED TESTING PROGRAMS AND APPROPRIATE SUPPLIER QUALIFICATION Here is an excellent LinkedIn post that I wanted to provide which summarizes the recent situation with FDA sending Nine FDA Warning Letters to OTC manufacturers and contract manufacturers about their expectations regarding Talc/Asbestos testing and raw material testing/supplier qualification overall. I think the author makes some good points that need to be considered as everyone looks at this situation. Here is the link (GO HERE FIRST): https://lnkd.in/g6pbe4KN An additional post regarding this should also be reviewed at: https://lnkd.in/gwsVEAbM Have you fully assessed your raw material testing, reduced testing criteria and supplier qualification programs for ALL your raw materials including both APIs AND Excipients? If not, it is now time to do this ASAP. FDA has made their expectations clear when Nine Warning Letters are sent out to OTC manufacturers that are very similar regarding this issue on the same day. I don't think it was an accident that all nine of these Warning Letters were sent out on June 2, 2026, one day after the new USP asbestos testing requirements became official on June 1, 2026!