FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2015 – NOW AVAILABLE

TOP FOUR OBSERVATIONS RETAIN SIMILAR ORDER TO 2013 AND 2014

In May 2016, I published the above Blog. There were almost 1,000 “hits” on this particular posting.  Because of its popularity, I am reposting it, and, if perhaps you did not view it, you may wish to view it at this time.

Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc.  This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those FDA’ CDER listing found within 21 CFR Part 211.

Please visit my Blog (Click Here) to learn more about the top four Observations as well as the other fifteen and those top Observations from previous years.