Compliance / FDA FSMA
FDA Food Safety Modernization Act
Signed into law on January 4, 2011, the Food Safety Modernization Act (FSMA) is the most sweeping reform of U.S. food safety laws in more than 70 years. It shifts the FDA's focus from responding to contamination to preventing it across the entire food supply chain — including how food is held and transported under temperature control.
The seven major rules
Preventive Controls for Human Food (21 CFR Part 117)
Requires registered facilities to implement a written food safety plan with hazard analysis, preventive controls, monitoring, corrective actions, verification, and records.
Produce Safety Rule (21 CFR Part 112)
Establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption.
Foreign Supplier Verification Programs (FSVP)
Importers must verify that foreign suppliers produce food meeting U.S. safety standards equivalent to domestic preventive controls or produce safety rules.
Sanitary Transportation Rule
Requires shippers, loaders, carriers, and receivers involved in transporting human and animal food by motor or rail to follow recognized sanitary practices, including temperature control.
Mitigation Strategies to Protect Food Against Intentional Adulteration
Requires covered facilities to prepare and implement a written food defense plan identifying significant vulnerabilities and mitigation strategies.
Section 204 — Food Traceability Rule (21 CFR Part 1, Subpart S)
Creates additional traceability recordkeeping for foods on the Food Traceability List. Compliance date: January 20, 2026. Requires Key Data Elements (KDEs) at Critical Tracking Events (CTEs) and the ability to provide records to FDA within 24 hours.
Recordkeeping & 21 CFR Part 11
FSMA requires written records of monitoring, corrective actions, and verification. When those records are kept electronically, they fall under 21 CFR Part 11, which sets criteria for trustworthy electronic records and electronic signatures — including audit trails, access controls, and system validation.
How FreshPulse helps
- Continuous, time-stamped temperature logs with immutable storage.
- Automated corrective-action workflows and e-signatures.
- FSMA 204 Key Data Elements captured at Critical Tracking Events.
- One-click audit packages for FDA inspectors within the 24-hour window.
- Sanitary Transportation records for shippers, carriers, and receivers.
Official sources
- FDA — Food Safety Modernization Act (FSMA)
- FDA — FSMA Final Rule on Requirements for Additional Traceability Records (Rule 204)
- 21 CFR Part 117 — Preventive Controls for Human Food
- 21 CFR Part 11 — Electronic Records; Electronic Signatures
This page is informational only and does not constitute legal or regulatory advice. Always consult the official FDA texts and a qualified advisor for your facility.