The FDA has been getting a little less predictable in the realm of microbiology. I first noticed the changes around January of this year (2025). Clickbait verbiage aside, there are two specific areas where we have seen not just an unmistakable change in FDA focus, but also a steep uptick in enforcement action. One is regarding microbial identifications and organism risk assessment (make sure you are subscribed to hear more on those topics). The other topic, which we will discuss here, concerns microbiological testing of water.

Microbial contamination continues to be the leading cause of recalls of drug and cosmetic products, so, understandably, the first reaction to microbial recovery may be one…

Is your laboratory testing partner ready for MoCRA? Cosmetics manufacturers around the globe have been busy registering their facilities with the United States Food &…