When your company receives notification from the FDA that your most recent inspection is classified as “VAI” (Voluntary Action Indicted), does that mean that you’re off the hook and can relax until the next inspection? Absolutely not! The assignment of VAI spans the spectrum from almost NAI (No Action Indicated) (maybe one minor FDA Form 483 (483) observation) to close to OAI (Official Action Indicated) (many inter-related observations, but not quite rising to OAI status). Taking appropriate steps once your firm receives VAI classification is advised. Here are the top four actions you should take upon receiving the notification.

    1. If the notification included the EIR (Establishment Inspection Report), read the EIR carefully for any additional concerns that the FDA might have had that didn’t make it into the 483 itself. If there are additional concerns, be sure to investigate them thoroughly and open CAPAs for them as you would for a 483 citation. Even though they didn’t make into to the 483 itself, it doesn’t mean that the next investigator won’t look for them.
    2. Continue to update the FDA on your progress in addressing the issues outlined in the 483. Even though the VAI status means that the FDA won’t be taking further action on this inspection, it’s good practice to continue to update the FDA until all of the CAPAs are closed.
    3. Review all of the observations to determine whether they can be expanded systemically and globally. Your initial response may have looked narrowly at only the observation itself, but it’s important to determine whether the issues are indicative of a systemic issue that might affect other processes, equipment, products, or facilities. The fastest way to a future notation of a repeat observation is to have something crop up again in another system or process. It may not be an exact repeat, but the FDA will characterize similar observations as repeat.
    4. Make sure that your CAPA effectiveness program is robust and will detect any ineffective CAPAs. If additional CAPAs are needed based on the effectiveness checks, these will need to be documented appropriately and communicated to the FDA if necessary.

 

If you haven’t already done it, start building your evidence binders. Evidence binders contain complete documentation for the completion of actions for each FDA observation. Even if the evidence resides in a QMS, it’s a good idea to have a copy of each item in the binder. Evidence binders do not need to be hard copy; they can be electronic. If they are electronic, make sure that they are in a format that allows easy access for reviewing or printing. It’s a best practice to appoint someone as the custodian of the binders or someone with overall responsibility for each observation, who is the final reviewer of the evidence to ensure that it addresses the issue in the observation.

Lastly, make sure that drift doesn’t enter the system inadvertently. It’s okay to knowingly, and with forethought, change a commitment that you made to the FDA. After all, a QMS isn’t static. However, you don’t want to be caught by making a change to a commitment and not recognizing it. And, if you do make a change, make sure to update or annotate the evidence binders accordingly.

VAI status may give you a sense of relief, but make sure you don’t let down your guard. These suggestions can help you on your way to continuous inspection readiness. Contact Lachman for all your inspection readiness needs as well as for responding to 483s and other FDA actions. Reach out to us at LCS@LachmanConsultants.com for a consultation.