21 CFR Part 1 – General Provisions & Foreign Supplier Verification (FSVP)

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / FSMA • Imports, Registration, FSVP, Transportation

21 CFR Part 1 contains the FDA’s core general provisions for foods entering U.S. commerce—spanning facility registration, prior notice of imports, administrative detention, Foreign Supplier Verification Programs (FSVP), sanitary transportation, and the FSMA traceability rule. It works alongside 21 CFR Part 117 (preventive controls), Part 111 (supplement cGMP), and Part 11 (electronic records).

“Part 1 is the gatekeeper: it decides who can import food, how they verify foreign suppliers, and what traceability and transport controls prove it’s safe.”

1) What It Is

Part 1 operationalizes FSMA at the borders and across the supply chain. It requires U.S. and foreign entities to register, notify FDA of incoming food shipments, verify foreign suppliers, keep traceability records for certain foods, and transport food under sanitary conditions.

Scope & application. Applies to importers, manufacturers, processors, packers, holders, transporters, and certain foreign entities whose products are shipped to the U.S. Dietary supplements and low-acid canned foods have tailored/modified requirements.

Key subparts teams cite most often:

• Subpart H (Registration of Food Facilities). U.S. and foreign facilities must register and renew; registration may be suspended if food poses a reasonable probability of causing serious adverse health consequences.
• Subpart I (Prior Notice of Imported Food). Importers/brokers must file prior notice before food arrives at the border.
• Subpart K (Administrative Detention). FDA may detain food that appears adulterated or misbranded.
• Subpart L (FSVP – 1.500+). Importers must evaluate hazards, approve/verify foreign suppliers, perform supplier audits or sampling as needed, and maintain records; FSVP importer identification (often DUNS) is required at entry.
• Subpart O (Sanitary Transportation – 1.900+). Shippers, loaders, carriers, and receivers must prevent contamination and temperature abuse through qualified equipment and written procedures.
• Subpart S (FSMA 204 Traceability – 1.1300+). Defines Key Data Elements (KDEs) and Critical Tracking Events (CTEs) for designated foods; requires electronic sortable records.

2) Compliance Architecture & Data You Must Control

Part 1 expects an end-to-end program linking supplier approval, receiving, transportation, and traceability to a single source of truth. Practically, that means:

• Supplier program. Hazard analysis, supplier approval, verification activities (audit, sampling, COA review), re-evaluation at least every 3 years or when hazards change (FSVP).
• Entry readiness. FSVP importer identified at entry; prior notice filed; records available on request.
• Receiving controls. Lot quarantine until verification passes; COA/spec match; temperature and seal checks where applicable.
• Transportation. Written procedures for equipment sanitation, temperature control, and pre-cooling (Subpart O).
• Traceability. Capture KDEs at each CTE for covered foods; maintain electronic, sortable records (Subpart S).
• Electronic records. Keep approvals, audits, monitoring, and corrective actions with identity, timestamps, and audit trails per Part 11.

3) FAQ

Q1. Who is the “FSVP importer”?
The U.S. party responsible for verifying the foreign supplier (often the U.S. owner/consignee at time of entry). Their identifier (commonly DUNS) must be transmitted at entry.

Q2. What records do I need for FSVP?
Hazard analyses, supplier approval rationale, verification results (audits, sampling, COAs), corrective actions, and re-evaluations—retained for FDA inspection.

Q3. How does Part 1 relate to Part 117?
Part 117 governs preventive controls inside domestic facilities. Part 1’s FSVP ensures foreign suppliers meet equivalent safety standards before product enters U.S. distribution.

Q4. What products trigger FSMA 204 traceability?
Designated high-risk foods (e.g., certain produce, cheeses, seafood) require KDE/CTE records under Subpart S; check if your items are on FDA’s Food Traceability List.

Q5. What does sanitary transportation require?
Written procedures, qualified equipment, training, temperature monitoring (as needed), and records demonstrating prevention of contamination and temperature abuse.

Q6. Where can I read Part 1?
See the eCFR for 21 CFR Part 1.

4) How It Relates to V5

V5 by SG Systems Global operationalizes Part 1 across supplier approval, receiving, transportation, and electronic traceability.

• Supplier Management & AVL. Approve suppliers, attach audits/COAs, and schedule verification—mapped to FSVP obligations.
• Quality-Enforced Receiving. Quarantine lots until checks pass; auto-block use if specs or COAs fail (Quality-Enforced Receiving).
• FSMA 204 Traceability. Capture KDEs/CTEs and keep electronic, sortable records tied to lots and shipments.
• Sanitary Transport Checks. Record seal numbers, temperatures, and equipment sanitation in WMS.
• Part 11 Controls. E-signatures, user access, and audit trails across approvals, receiving, and transport logs (Part 11).
• API Integrations. V5 Connect API links brokers/ERPs for entry data, supplier docs, and shipment status.

End-to-end example. A foreign supplier ships a spice blend. Prior notice is filed; V5 verifies the supplier’s approval status and recent audit, quarantines the lot at receiving, checks COA vs specs, logs container temperatures and seals, and captures KDEs for FSMA 204. Only after QA e-signs release does WMS allow consumption into production.

Primary References:
• eCFR: 21 CFR Part 1
• Preventive Controls (FSMA): 21 CFR Part 117
• Dietary Supplements: 21 CFR Part 111
• Electronic Records: 21 CFR Part 11
• Receiving & CoA Flow: Quality-Enforced Receiving | Certificate of Analysis | WMS