A company receives multiple complaints regarding text included on a recently launched label. What action should the regulatory affairs professional take FIRST?

In this scenario, the appropriate first action for the regulatory affairs professional is to compare the approved text with the product label. This step is crucial because it allows the professional to establish whether the complaints regarding the label's text are valid and rooted in discrepancies between what was approved and what is currently being displayed. By conducting this comparison, the professional can determine if there is a potential regulatory issue, such as incorrect or misleading information being presented on the label.

Investigating the specific content of the label against the approved documentation helps ensure that any subsequent actions, whether they involve communicating with production teams, notifying regulatory authorities, or considering a product recall, are based on accurate and substantiated findings. This methodical approach underpins the regulatory compliance process and helps in making informed decisions that prioritize consumer safety and adherence to regulatory standards.

Other actions, such as recalling the product or notifying regulatory authorities, would be premature without first verifying the facts concerning the label's text. Additionally, informing the production team should also follow this verification process to ensure that they are aligned and can address any potential changes needed based on the investigation results.