🇺🇸 Live Food Safety & Manufacturing

FSMA Food Safety (21 CFR 117)

Requires food facilities to implement a food safety plan with hazard analysis and risk-based preventive controls for human food. Applies to domestic and foreign food manufacturing, processing, and storage facilities.

View official source document

Rules extracted

778

Obligations decomposed

12.8x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

778

Obligations

12.8x

Decomposition ratio

Each rule is decomposed into an average of 12.8 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 778 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in FSMA 21 CFR 117 is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: FSMA Food Safety (21 CFR 117)
Regulatory body: Food and Drug Administration
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: September 17, 2015
Industry: Food Safety & Manufacturing
Official source: View source document ↗

Who this applies to

food manufacturersprocessorspackersholders of human food

Key requirements

hazard analysis
preventive controls
monitoring procedures
corrective actions
verification activities
supply chain program
recall plan
allergen controls

Frequently asked questions about FSMA 21 CFR 117

What is FSMA 21 CFR 117?

Who does FSMA 21 CFR 117 apply to?

FSMA 21 CFR 117 applies to food manufacturers, processors, packers, holders of human food.

How many obligations does FSMA 21 CFR 117 contain?

AuditDSS has decomposed FSMA 21 CFR 117 into 778 atomic obligations from 61 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of FSMA 21 CFR 117?

The key requirements include: hazard analysis, preventive controls, monitoring procedures, corrective actions, verification activities, supply chain program, recall plan, allergen controls.

How can I assess my FSMA 21 CFR 117 compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 778 FSMA 21 CFR 117 obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces FSMA 21 CFR 117?

FSMA 21 CFR 117 is enforced in United States by Food and Drug Administration.

When did FSMA 21 CFR 117 come into effect?

FSMA 21 CFR 117 became effective on September 17, 2015.

What industry does FSMA 21 CFR 117 apply to?

FSMA 21 CFR 117 is primarily relevant to the Food Safety & Manufacturing industry. AuditDSS covers 61 regulations in this industry sector.

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Policy

High-level commitments and governance framework covering FSMA 21 CFR 117 requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

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Multi-regulation

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AI maps against 778 obligations

Your document is scored against every obligation in FSMA 21 CFR 117. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.