Active Enforcement Period
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Surprise FDA Audit?
The FSMA 204 deadline has passed. If an inspector walked into your facility today and asked for the trace history of a specific lot code, how long would it take you?
Hours? Days?
Generate compliant sortable spreadsheets
Trace ingredients backwards and forwards instantly
Identify exactly which customers received affected batches
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FSMA 204 Compliance: Common Questions
What is FSMA 204 and who does it apply to?
FSMA 204 (Section 204 of the Food Safety Modernization Act) requires food manufacturers, processors, packers, and holders of certain high-risk foods to maintain detailed traceability records — including lot codes, quantities, and locations — for every ingredient and finished product. Enforcement began in January 2026. Small businesses (fewer than 10 full-time employees or less than $1M in average annual revenue) were exempt, but most growing food manufacturers fall under the rule.
What records does FSMA 204 require food manufacturers to keep?
FSMA 204 requires three categories of records: (1) Traceability Lot Codes (TLCs) assigned at each Critical Tracking Event (CTE), (2) Key Data Elements (KDEs) such as location identifiers, dates, quantities, and reference document numbers for each CTE, and (3) a Traceability Plan describing how your business assigns lot codes and maintains records. Records must be kept for 2 years and provided to the FDA within 24 hours of a request.
How long do you have to respond to an FDA records request?
Under FSMA 204, you must provide traceability records to the FDA within 24 hours of a request (or a timeframe agreed upon with the FDA). Records must be in an electronic sortable spreadsheet format. This is why paper logs and disconnected spreadsheets are high-risk — manually compiling a compliant report under time pressure is extremely difficult.
What happens if you fail an FDA traceability audit?
Failure to comply with FSMA 204 can result in Warning Letters, mandatory product holds, and potential facility shutdown orders. Beyond regulatory consequences, inadequate traceability records during a recall event can dramatically increase the scope of a recall — meaning more product pulled, more customer impact, and higher financial loss.
How does SauceControl help with FSMA 204 compliance?
SauceControl automatically assigns and tracks lot codes at every Critical Tracking Event — receiving, production, and shipping. When you need to produce an FSMA 204-compliant traceability report, the system generates a sortable spreadsheet with all required Key Data Elements in under 2 minutes. It also lets you run mock recalls to verify your records are complete before an actual inspection.
Can I run a mock recall drill in SauceControl?
Yes. SauceControl's mock recall tool lets you select any lot code and instantly see the full trace chain — where the ingredients came from, which production batches used them, and which customer orders contain the affected product. The entire forward and backward trace takes less than 2 minutes. Running quarterly mock recalls is the best way to confirm your traceability data is complete and accurate before the FDA asks.