Tag Archive: 483

Jun 08 2012

Warning: Your “Check CAPA” Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jun 08 2012

Warning: Your “Check CAPA" Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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May 26 2010

What everyone should know about responding to Warning Letters.

It takes less time to do something right than it takes to explain why you did it wrong. -Lee’s Law Interestingly enough, many people do not take advantage of the Warning Letters posted on the FDA website.  Personally, I always prefer to learn from the mistakes of others, rather than flounder through the same mistakes …

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