FDA issued a draft guidance Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection to help human and animal drug and biologics manufacturers prepare adequate responses to the agency when the manufacturer receives a form 483 at the end of an inspection. The guidance provides recommendations on how to submit a clear and well-organized response to the agency that outlines the manufacturer’s plans to remediate the observations highlighted in the 483 and any other needed corrective and preventive actions.