Fda 111 requirements for all product types
By Jake, founder · Published · Updated
fda 111 sets 10 requirements for every product type: 10 documentary (a record must be on file or a property absent), each carrying its primary-source citation below, last verified 2026-07-24.
The requirements
| Requirement | Category | Limit | Unit | Basis | Method | Status | Source |
|---|---|---|---|---|---|---|---|
| Established product specifications (identity, purity, strength, composition, contamination limits)established_product_specifications | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.70(b)(3), (e)verified 2026-07-24 |
| Identity test on every lot of every dietary ingredient before useingredient_identity_testing | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.75(a)(1)(i)verified 2026-07-24 |
| Finished-batch verification (every batch or a sound statistical sampling plan)finished_batch_verification | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.75(c); 111.80(c)verified 2026-07-24 |
| Quality-control batch-release decision; absolute release prohibitions observedqc_batch_release_decision | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.123(a)(8), (b); 111.127(h)verified 2026-07-24 |
| Master Manufacturing Record on file per formulation and batch size (Subpart H)master_manufacturing_record | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.205, 111.210verified 2026-07-24 |
| Batch Production Record on file for every batch (Subpart I)batch_production_record | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.255, 111.260verified 2026-07-24 |
| Records retained 1 year past shelf-life date, or 2 years past distribution of the last batchrecords_retention | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 111.605verified 2026-07-24 |
| Serious adverse events reported via MedWatch within the statutory window; adverse-event records retainedserious_adverse_event_reporting | identity | on file | n/a | n/a | n/a | Mandatory | 21 U.S.C. 379aa-1(b)–(e) (FD&C Act §761)verified 2026-07-24 |
| Contract-manufacturer facility registration number captured + attestation; biennial renewal window tracked (database is not public)manufacturer_facility_registration | identity | on file | n/a | n/a | n/a | Mandatory | 21 CFR 1.230(b); FD&C Act §415. Registration database is non-public (21 U.S.C. 350d).verified 2026-07-24 |
| Brand owner retains ultimate responsibility for non-adulteration when contracting outcannot_contract_out_responsibility | identity | on file | n/a | n/a | n/a | Mandatory | 72 FR 34752, 34790 (2007) preamble; FDA warning-letter doctrine (Phi Sciences, 2019)verified 2026-07-24 |
Advisory rows have no authoritative published number, so no value is invented for them. Per-day bases convert to a concentration limit only with a specific product's serving size, so no bare concentration is stated here.
Who is responsible
The brand owner, even when manufacturing is contracted out. A quality agreement can allocate who performs each task; it cannot transfer the responsibility for a correctly documented product that meets these requirements. In practice: the manufacturer runs the tests and holds the records, and the brand must be able to produce them, current and complete, when a platform, retailer, or inspector asks.
What a certificate of analysis (COA) needs to show to clear this review
A COA that clears review against this table has, at minimum:
- Laboratory identity with contact details and an accreditation reference: verifiers contact the issuing lab to confirm authenticity.
- Sample identification: product name and lot code matching the batch, with report, manufacture, and expiry dates that agree with each other.
- One row per requirement above: the analyte as tested, the numeric result with its unit, the method, and the lab's own specification. “Conforms” without a number is not a result a reviewer can accept.
- Detection limits on non-detects: “ND” only demonstrates compliance when the method's detection limit is at or below the required limit.
- Current date: verification programmes cap document age; an expired COA is unusable regardless of its content.
Common questions
- Who is responsible for meeting fda 111 requirements?
- The brand owner. Responsibility for individual tasks can be allocated to a contract manufacturer through a quality agreement, but the responsibility for a correctly documented product that meets these requirements cannot be contracted out. The manufacturer holds the records; the brand holds the liability.
- Where do these values come from?
- Every row carries its own primary-source citation and the date it was last verified (2026-07-24). Nothing on this page is estimated: values marked advisory have no authoritative published number, and no number is invented for them.
- What happens when a value changes?
- The dataset is versioned. When a set is superseded, this page regenerates with the new values and the update date changes, and customers with affected SKUs are told what changed and what is now needed.
- How do I know if my current documents meet these requirements?
- Upload them to the free gap check. It reads each document, compares every extracted value against this table, and names what is missing, with the citation, before any reviewer does.
Would your documents pass against this table?
The agent reads your supplement label or test report against these rows, compares every value, and names what is missing with the citation. Get in touch and we will take you through it on a document of yours.