food-facility-registration
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...
Full skill instructions
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.
Gather before drafting:
| Field | Value |
|---|---|
| Document Title | FDA Food Facility Registration |
| Facility Legal Name | |
| Submission Date | |
| Submission Type | New / Renewal / Update |
| Contact for Filing |
| 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 |
List each product by FDA category code with:
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 |
The U.S. Agent serves as FDA's primary communication link for all inquiries.
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.
Draft language affirming:
Include signature block: Authorized Signatory, Title, Date, Signature.
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