When Will FSVP Inspections of Produce Importers Begin? In the Foreign Supplier Verification Programs (FSVP) regulation, compliance dates are set up so that, for many importers, compliance dates are linked to when the foreign supplier must meet the requirements of the new FDA Food Safety Modernization Act rules (specifically, when the foreign supplier must meet…
Produce Safety Inspections
The FDA and National Association of State Departments of Agriculture (NASDA) and our state partners have collaborated to develop two new documents to be used in support of produce inspections. Form 4056 (Produce Farm Inspection Observations) The first document is the Form FDA 4056, “Produce Farm Inspection Observations.” This form represents a new way of…
Press Releases from Prior Years
Search the FDA.gov Web Archive Use this search function to search for text in pages and files in the FDA.gov Web Archive. After you click Search the Archive, the results appear on the FDA.gov Archive-It site.Please note: To search for OCI press releases, begin your search with the term ‘criminal investigations’ to limit the search….
Inspection Classification Database
The Food and Drug Administration (FDA) conducts inspections of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts. FDA discloses a segment of inspection information to help improve the public’s understanding of how the FDA works to protect the public health….
Inspection Observations
FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product…
ORA Outbreak Response Field Guides
Foodborne outbreak investigations have been increasing. This has been influenced by direct food safety hazards and our improved outbreak detection capability. FDA is working toward reducing foodborne outbreaks by continuing a strong, effective surveillance, compliance, and enforcement program, supporting preventative controls, supporting corporate accountability to understand and have confidence in their supply chain, and providing…
Bioresearch Monitoring Program Information
FDA’s Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as,…
Chapter 3 – Devices – Sub Chapters 355 – 398
Chapter 3 – Devices – Sub Chapters 355 – 398 In this section: Manual of Compliance Policy Guides Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Manuals Manual of Compliance Policy Guides Chapter 3 – Devices – Sub Chapters 355 – 398 Compliance Manuals Sub Chapter 355 – Orthop. and Phy. Med. Sub Chapter…
Chapter 5 – Food, Colors, and Cosmetics
Sub Chapter 500 – Additives Sub Chapter 505 – Bakery Products Sub Chapter 510 – Beverages Sub Chapter 515 – Candy and Sugar Sub Chapter 520 – Canned Foods Sub Chapter 525 – Condiment Industry Sub Chapter 527 – Dairy Sub Chapter 530 – Dietary Supplements Sub Chapter 535 – Edible Oils Sub Chapter 537…
Chapter 5 – Food, Colors, and Cosmetics – Sub Chapters 570 – 590
Chapter 5 – Food, Colors, and Cosmetics – Sub Chapters 570 – 590 In this section: Manual of Compliance Policy Guides Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Manuals Manual of Compliance Policy Guides Chapter 5 – Food, Colors, and Cosmetics – Sub Chapters 570 – 590 Compliance Manuals Sub Chapter 570 –…