On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for foreign and domestic human and animal drug establishments manufacturing drugs regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM). The guidance is also intended for combination product manufacturers for which CDER or CBER is the lead center.