FSMA 204 Traceability Pack

Name: FSMA 204 Traceability Pack
Author: fmcg.network Core Team

Format required Critical Tracking Event (CTE) and Key Data Element (KDE) records for FDA 24-hour FSMA 204 inspection requests and identify missing lot codes before audits.

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Which market this reads

What this check reads: United States. No other market is covered.

Grounded in FDA FSMA 204 / 21 CFR Part 1 Subpart S public rules. Formats CTE/KDE traceability records into electronic sortable spreadsheet tables. Refuses legal compliance verdicts.

What it does

Helps US food facilities format Critical Tracking Event (CTE) and Key Data Element (KDE) records for FDA FSMA 204 / 21 CFR Part 1 Subpart S compliance without issuing legal verdicts.

Ask it like this

you
What Key Data Elements are required for a Receiving Critical Tracking Event under FSMA 204 (21 CFR 1.1330)?

You never name it yourself. Your assistant picks the right tool: us_fsma_204_traceability_pack__lookup_fsma_204_kde_requirements

What you give it

What to give	Kind of value	Needed?	Notes
cte_event	string	yes	lookup: Critical Tracking Event type (Receiving, Transformation, Shipping, Creation)
cte_type	string	yes	validate: Critical Tracking Event type for batch validation
records	array	yes	validate: array of KDE record objects containing traceability_lot_code, location_identifier, event_date, product_description, quantity

What you get back

What comes back	Kind of value	Notes
required_kdes	string	lookup: required KDE fields under 21 CFR Part 1 Subpart S
cfr_reference	string	lookup: specific 21 CFR citation
validated_count	integer	validate: count of records validated
missing_kde_count	integer	validate: count of missing mandatory fields
export_ready	boolean	validate: true if ready for 24-hour electronic export request
disclaimer	string	states data formatting and checklist results, never issues legal compliance verdicts

Sources

Title 21 CFR Part 1 Subpart S (21 CFR 1.1300 through 1.1465)
FDA FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability List)

Who wrote this

Every capability is written by one named publisher. You see who stands behind an answer, and you can take the conversation further with them directly.

fmcg.network Core Team

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How uncertainty is handled

This check reports a confidence score with every answer. Below 80 out of 100 nothing is guessed: the uncertain items go to a review queue and the answer comes back marked "needs review".

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