Tag Archive: warning letters

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 2011

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

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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May 18 2010

Bad Ads – FDA Recruits Health Care Providers to Combat Misleading Advertising

If your advertising goes unnoticed, everything else is academic. – William Bernbach Fierce reported that the “FDA has issued 186 warning letters so far this year”.  (Looking at that number, they must mean “warning and untitled letters” which are frequently conflated). Assuming that 1) this covers January through April only and 2) this pace continues, …

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May 17 2010

DDMAC Sends Warning Letter Over Unbranded Websites

If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis:  DDMAC Sends Warning Letter Over Unbranded Websites.  That’s right, a warning letter over websites that contained no “direct” references to a product…although, as we’ll see, the indirect references were too direct for the …

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Apr 29 2010

FDA Warning Letters vs Untitled Letters

History is a vast early warning system. – Norman Cousins The Drug and Device Law blog recently published two short posts on FDA warning letters.  The first post mistakenly described an untitled letter, referenced in a lawsuit, as a warning letter.  The second corrects the mistake and then gives a nice description of the difference …

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Apr 22 2010

First Example of Proposed DTC Rules in Effect?

No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time. – James Arthur Baldwin Hey, remember those proposed DTC advertising rules that the FDA published recently?  Well, we may be getting a preview of a world where those rules are in effect. …

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