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...]
FDA’S CDER SUMMARIZES TOP TEN 483 OBSERVATIONS AT PDA/FDA MEETING IN BALTIMORE (9/12)
COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. At this year's PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date. The Observations within the top ten usually do not change --- although their frequency may vary. Where a specific section is indicated, the Title indicates … [Read more...]
LEARN ABOUT THE FORM FDA 483s THAT LED TO THE NOVARTIS RECALL (1/08/12)
SPECIFIC OBSERVATIONS POINT TO THE EVENTUAL LINCOLN, NE RECALL Novartis Consumer Health, Inc. (NCH) received a Form FDA 483 containing 10 Observations representing 23 pages on January 20, 2012. Several of the Observations were similar to those received in July 2011. Observation 1 is the most inclusive and reads as follows: “OBSERVATION 1 QUALITY SYSTEM: Your Quality Unit … [Read more...]
