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’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014
TOP FOUR OBSERVATIONS REMAIN SIMILAR IN NUMBER TO 2013 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 found within 21 CFR Part 211. Interestingly, … [Read more...]
THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s
TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR). It was completely “rolled out†in October 2002. For each “Objectionable Condition†(FDA 483 Observation), TurboEIR requests the inspection team to choose a … [Read more...]
FDA’S CDER LISTING OF TOP EIGHTEEN OBSERVATIONS FOR 2013
TOP FOUR OBSERVATIONS INCREASE SIGNIFICANTLY OVER 2012 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 Center for Drug Evaluation and Research (CDER) and will concentrate upon those found within 21 CFR Part 211. Interestingly, while … [Read more...]
