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  • Lorrie D. Divers, President, QRCP Solutions, Inc.

Cautionary Tales

Last week on LinkedIn, I shared a recently issued FDA Warning Letter that generated a lot of views and ‘likes.’ The topic of the regulatory citation in the Warning Letter was clinical trials records retention, always a point of interest. But it seems a lot of people, not just QA and regulatory types like me, like reading FDA Warning Letters, but why?

The primary reason to read them is because they offer considerable information and insight into the real world application of clinical trials regulations. Warning Letters follow a specific format and always contain:

  • The specific regulation the inspection observation pertains to

  • Details of the inspection observation

  • Any information the clinical investigator or study site personnel may have provided during the inspection pertaining to the observation

These three items reveal the FDA’s perspective and provide clear ‘how not to’ advice. They illustrate in detail how the FDA applies a specific regulation to actual events, activities, and documentation (or lack thereof). Details about unacceptable actions or documentation are provided. Sort of like a Aesop fable, learning what/how not to do can be a powerful lesson.

The text of the Warning Letter may also provide some indication of how behavior or actions during an inspection was perceived, positively or negatively, by the FDA investigator (inspector) and interpreted by the Center in Washington DC. This can be subtle, but years of experience with regulatory inspections helps me focus on what may be there ‘between the lines.’

Such letters from the FDA will also include:

  • Details of the clinical investigator’s post-inspection response, if any

  • The FDA’s acceptance or non-acceptance of the response and why

Again, the comments on post-inspection responses may be positive but more often then not in Warning Letters, the FDA indicates that the clinical investigator’s response is “inadequate.” The two most common reasons the FDA appears to find a response unacceptable are:

  • Because insufficient details are provided in order for the FDA to assess whether the corrective, and especially the preventive action, will be effective to ensure regulatory compliance; or

  • Because the response indicates that the clinical investigator continues to demonstrate that she or he does not understand their regulatory and/or ethical obligations – and the FDA is not usually subtle in their response to that!

For everyone involved in clinical research, I also encourage you not to limit your Warning Letter reading to just those issued to Clinical Investigators or Sponsor/Monitor/CROs. Other regulatory areas, particularly GLP and GMP related Warning Letters, can often reveal the FDA’s thinking on topics equally applicable to GCP such as computer systems, data integrity, and generalizable quality system elements. These non-GCP Warning Letters may require a bit more interpretation to understand how they might apply to clinical trials, but they can also help us all improve and comply. And that’s the goal of learning from cautionary tales!

What are some of your ‘favorite’ FDA Warning Letters and lessons learned from them that have helped you and your organization?

If you need help interpreting recent FDA Warning Letters, or would like to learn more about how QRCP Solutions, Inc. can help you with quality, regulatory compliance or process improvement, please contact us at

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