In clinical research this phrase is used to emphasize the importance of complete and accurate documentation to site staff.  Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”

While working on a recent project involving researching FDA warning letters, it astonished me the number of investigators and investigative sites who had issues with informed consent.  I was surprised at the seemingly little familiarity study staff had regarding Federal Regulations when it came to the informed consent and the consenting process.

Dr. K. Kringle
Adjunct Professor of Child Psychology
Far Northern University

Following an FDA inspection and exit interview, the FDA investigator will discuss the findings from an inspection and if deficiencies are found, a FDA 483 Inspectional Observations may be issued. The 483 describes any inspection findings that represent deviations from applicable agreements and regulations. The response to a FDA 483 is crucial. An article published in GxP Perspectives highlights sentence fragments from Warning Letters which seem to indicate a missed opportunity to avoid a Warning Letter following an FDA 483: