Open AccessFDA Warning Letter: Avoidance and Advice
Author(s) -
Winchell T.
Publication year - 2011
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.488
Subject(s) - receipt , audit , advice (programming) , letter to the editor , scope (computer science) , business , operations research , medicine , psychology , operations management , actuarial science , engineering , computer science , accounting , advertising , programming language
Summary This article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd.