1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection March 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-1504

Docket Number:
FDA-2025-D-1504
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
Office of Inspections and Investigations

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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.

Back to Top