Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection." This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by FDA whose drugs are 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 purpose of this guidance is to assist manufacturers who choose to respond to FDA when they receive an FDA Form 483 Inspectional Observations (FDA 483) at the conclusion of a drug inspection to assess conformity with current good manufacturing practice (CGMP) requirements.