{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.\" This guidance is intended for foreign and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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/03/09/2026-04578.html","cfr_references":[],"citation":"91 FR 11325","comment_url":null,"comments_close_on":"2026-05-08","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by May 8, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-1504"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-03-09","updated_at":"2026-03-09T10:57:21.333-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-1504-0001","allow_late_comments":false,"id":"FDA-2025-D-1504-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-1504","title":"Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability"}],"document_number":"2026-04578","effective_on":null,"end_page":11326,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/09/2026-04578.xml","html_url":"https://www.federalregister.gov/documents/2026/03/09/2026-04578/responding-to-fda-form-483-observations-at-the-conclusion-of-a-drug-cgmp-inspection-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-04578?publication_date=2026-03-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-09/2026-04578/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1879,"last_updated":"2026-05-18 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-09/pdf/2026-04578.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04578.pdf?1772804716","publication_date":"2026-03-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/09/2026-04578.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-D-1504","supporting_documents_count":0,"docket_id":"FDA-2025-D-1504","document_id":"FDA-2025-D-1504-0001","regulation_id_number":null,"title":"Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-05-01T13:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11325,"subtype":null,"title":"Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability","toc_doc":"Responding to Food and Drug Administration Form 483 Observations at the Conclusion of a Drug Current Good Manufacturing Practice Inspection","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}