Actions you should take during those critical first 24 hours after closing an FDA inspection

FDA 2

Much has been written and said about preparing for an FDA inspection (or other regulatory inspection). However, I have not seen anything written which describes what actions are needed during the critical first 24 hours after the inspection closes. Certainly, you need to begin preparing any needed response to the inspection results, but there are a number of significant actions you must take during the first day post-inspection that could very well determine your success or failure for the next inspection.

Let’s take a look at those critical “first 24 hours” actions:

  1. Communicate results to management – Most firms have a policy or standard practice that communication to management regarding inspection results is required immediately after the closing conference. This is important. However, it is also important to communicate to management any other details or actions that could elicit future concerns (such as a Warning Letter) or items that should be addressed in other similar facilities. FDA expects that actions taken be global in application, so other sites should be made aware quickly of any issues that could apply there.
  2. Thank individuals involved in managing the inspection – It is essential that one of the first actions you take after the inspection is to personally thank those that worked so diligently to manage the inspection well. Those in the front room, back room, subject matter experts, and those working behind the scenes need to be identified and thanked for their work and actions leading up to and through the inspection. Many of these individuals worked far beyond their normal work schedule during the inspection and, in some cases, delayed vacations, missed family events, or postponed other important work to ensure the inspection was successful. Consider doing something special for key individuals, such as a gift certificate for two to dinner. Take the time very quickly after the inspection close-out to thank them both privately and publicly.
  3. Thank the entire site for supporting the inspection – A successful inspection result is always tied to the diligence and efforts of the entire site. A site-wide communication summarizing the basic results of the inspection and thanking the site for their efforts goes a long way to encourage future compliance and improvement activities.
  4. Begin laying the groundwork for the next inspection – In most cases, the data and information that will be reviewed during the next inspection begins the day after the inspection closes. The days after an inspection is NOT the time to become lax or less diligent. Emphasize to your inspection management team, the site management team, and all individuals at the site that it is important to remain diligent and exercise a high level of compliance every day and in every activity. This communication can be included in the site-wide communication mentioned above, a site-wide meeting, video, or other means, but it is important that you emphasize continued and ongoing diligence.
  5. Initiate actions to capture and sustain positive momentum – In many cases, the teamwork, effort, and cross-functional camaraderie experienced during an inspection is unmatched by any other activity that occurs at the site. For the period of the inspection, everyone is singly focused on a positive inspection result. Utilize this momentum and work to sustain it. Celebrate this success with a pizza party or other event. Utilize this momentum to tackle other important site projects. Quick action can ensure that you don’t merely get “back to normal” the day after the inspection closes.
  6. Assign responsibilities and actions for any needed formal response – The inspection may result in the need for a formal response back to FDA (or other regulatory agency). Verbal or written items should be addressed comprehensively, so beginning action early and assigning responsibilities for initial/immediate actions are needed early. These do not need to be completed in the first day, but individuals should begin these activities as soon as possible after the closing.
  7. Assign responsibilities and actions for any new “lessons learned” or “close calls” – Most inspections result in “close calls” or “lessons learned.” Assigning responsibilities for actions associated with these should also be made soon after the closing. Speedy action may improve quality, improve compliance, or reduce other risks.

The key point is that it is good to celebrate the conclusion of a regulatory inspection, especially if the result is positive. However, there are some actions you should take within the first workday after the inspection to ensure a smooth transition back to “normal”, to ensure that key contributors are recognized, and to ensure that actions are taken to set the stage for an even better result on the next inspection.

Good luck on your next inspection!

 

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