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 FORM 483 FREQUENTLY ASKED QUESTIONS
OBTAIN THE ANSWERS TO THE QUESTIONS THAT EVERYONE ASKS This Blog site periodically provides 483s and Warning Letters as well as commentary as a service to its clientele. A question frequently asked is “when is a 483 issued as well as what are the implications of a 483”. The FDA has recently issued a “FDA Form 483 Frequently Asked Questions” on their web site that addresses … [Read more...]
FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS
USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [Read more...]
SMITHKLINE BEECHAM, LTD, CORK IRELAND RECEIVES WARNING LETTER FROM FDA (03/18/14)
FIRM FAILS TO SUFFICIENTLY INVESTIGATE PHARMACEUTICAL WASTE CONTAMINATION EVENT During an FDAÂ investigation of SKBÂ in Cork, Ireland, the FDA encountered an unusual situation where the pharmaceutical waste tank was found to have contaminated various other tankage used to manufacture APIs. Part of the rationale provided by SKB was that no reason existed … [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...]
