| name | food-facility-registration |
| title | FDA Food Facility Registration |
| 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. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/food-facility-registration |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | regulatory |
| language | en |
| tags | ["drafting","memo"] |
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:
- Facility identity — legal name, physical address (no P.O. Box), trade/DBA names, DUNS (if available)
- Parent company — name, address, DUNS (if not independently owned)
- Food product categories — all FDA product category codes for activities at the facility
- Operational type — manufacturing/processing vs. storage/distribution
- U.S. Agent (foreign facilities only) — name, U.S. physical address, phone, email
- Registration number — for renewals or updates only
- Authorized signatory — name, title, binding authority
Quick Start
- Confirm facility is not exempt under 21 CFR 1.226 (retail, restaurants, nonprofits, fishing vessels, farms)
- Determine submission type: New | Renewal | Update
- Collect all prerequisites above
- Draft sections in order below
- 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 |
