The First FDA Warning Letter on GMPs

What appears to be the first publicly posted FDA Warning Letter related to a GMP inspection of a dietary supplement manufacturer is available on the FDA website, and it is worth a read. Click here to view the letter. Documentation and SOPs seem to be major issues, and this was one of the main points made by FDA's Carl Reynolds during his featured presentation at SupplySide East a couple weeks ago. FDA does not immediately make all warning letters available on its site, so there are likely more that have been sent. Thanks to industry attorney Marc Ullman for finding this and sending it out in his FYI email update.

From conversations I have had with people at FDA, the agency seems to be unimpressed with industry's understanding of and compliance with the GMPs. This is concerning, since the rule was published by FDA nearly three years ago. Since that time, there have been countless seminars, workshops, training programs, webinars, conferences and articles available about GMP compliance. After begging for the release of the GMPs for nearly 13 years following the passage of DSHEA, industry has an obligation to understand them and comply. Hopefully this warning letter is the exception and not the rule.