TOP FOUR OBSERVATIONS RETAIN SIMILAR ORDER TO 2013 AND 2014 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 … [Read more...]
FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012
COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. Enclosed are the "top fifteen" Observations. The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies of various Observations have … [Read more...]
