Warning Letter Trend Suggests Crackdown On Contract Manufacturing

When FDA wants to make a point to the pharmaceutical industry, it often will do it by sending out a flood of warning letters that sound very similar to each other. Earlier in 2013, FDA sent out eight warning letters to various companies during flu season in America, which warned about making improper claims about its drug products. In 2012, the agency also sent about 10 warning letters to various foreign manufacturers after they did not register their plants with FDA.

But sometimes we see that admonitions from FDA are even more subtle. For example, the agency recently sent three warning letters to three companies that make dietary supplements – Natures Health Options, Body Systems and Gulcorell. We see a warning letter trend here that is worth noting.