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name: food-facility-registration language: en description: Drafts an FDA Food Facility Registration under FSMA and 21 CFR Part 1, Subpart H (21 U.S.C. 350d). Covers facility identity, food product categories, U.S. agent designation for foreign facilities, and certification language. Use when preparing new FDA facility registrations, biennial renewals, or registration updates for domestic or foreign food facilities. tags:

• drafting
• memo
• regulatory

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FDA Food Facility Registration

Drafts a registration filing under 21 CFR Part 1, Subpart H for domestic or foreign facilities manufacturing, processing, packing, or holding food for U.S. consumption.

Prerequisites

Gather before drafting:

1. Facility identity — legal name, physical address (no P.O. Box), trade/DBA names, DUNS (if available)
2. Parent company — name, address, DUNS (if not independently owned)
3. Food product categories — all FDA product category codes for activities at the facility
4. Operational type — manufacturing/processing vs. storage/distribution
5. U.S. Agent (foreign facilities only) — name, U.S. physical address, phone, email
6. Registration number — for renewals or updates only
7. Authorized signatory — name, title, binding authority

Quick Start

1. Confirm facility is not exempt under 21 CFR 1.226 (retail, restaurants, nonprofits, fishing vessels, farms)
2. Determine submission type: New | Renewal | Update
3. Collect all prerequisites above
4. Draft sections in order below
5. Include regulatory preamble and certification verbatim

Output Sections

Cover Page

Field	Value
Document Title	FDA Food Facility Registration
Facility Legal Name
Submission Date
Submission Type	New / Renewal / Update
Contact for Filing

Section 1 — Facility Information

Field	Notes
Legal facility name
Trade/DBA names	All operating names
Physical address	Street address; no P.O. Box
Mailing address	If different from physical
DUNS number	Optional
Phone / Email
Parent company name & address	If applicable
FDA Registration Number	Renewals/updates only

Section 2 — Food Product Categories

List each product by FDA category code with:

• Category code and description
• Activity type: Manufacturing/Processing | Packing | Holding/Storage | Distribution

Section 3 — U.S. Agent (Foreign Facilities Only)

For domestic facilities: mark Not Applicable — Domestic Facility.

Field	Requirement
U.S. Agent legal name
U.S. physical address	Must be in the United States
Phone	Reachable during all business hours
Email

The U.S. Agent serves as FDA's primary communication link for all inquiries.

Section 4 — Regulatory Preamble

Include verbatim or substantially similar:

This registration is submitted pursuant to Section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) and the implementing regulations at 21 CFR Part 1, Subpart H. Registration does not constitute FDA approval of the facility or its products, nor does it exempt the facility from any other applicable FDA requirements.

Section 5 — Certification and Attestation

Draft language affirming:

• Submitter has authority to legally bind the facility
• All information is true, accurate, and complete
• Facility agrees to permit FDA inspection and make FD&C Act records available

Include signature block: Authorized Signatory, Title, Date, Signature.

Pitfalls and Checks

• Exemption check — Always verify 21 CFR 1.226 exemptions before drafting
• Biennial renewal window — October 1 – December 31 of each even-numbered year
• Material changes — Must update registration within 60 days of any change
• Enforcement risk — Failure to register or update may result in administrative detention or import refusal
• Submission channel — Preferred: FDA Food Facility Registration Module (FFRM); note paper option if applicable
• Field labeling — Mark optional vs. required fields clearly to avoid submission errors
• Jurisdiction — U.S. federal filing only; no state-level analog required