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2 changes: 1 addition & 1 deletion frontend/src/app/fsma-204/page.tsx
Original file line number Diff line number Diff line change
Expand Up @@ -279,7 +279,7 @@ export default function FSMA204BusinessGuidePage() {
<Card variant="inset" padding="compact">
<p className="font-mono text-label uppercase text-re-text-muted">Without a system</p>
<p className="mt-3 text-ui text-re-text-secondary">
Dig through paper records, spreadsheets across multiple computers, call suppliers for missing info. Typical response: 3-5 days, incomplete.
Dig through paper records, spreadsheets across multiple computers, call suppliers for missing info. The rule does not wait: records must be provided within 24 hours of an FDA request, or within some reasonable time to which FDA has agreed (21 CFR 1.1455(c)(1)).
</p>
</Card>
<Card padding="compact">
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4 changes: 3 additions & 1 deletion frontend/src/app/pricing/page.tsx
Original file line number Diff line number Diff line change
Expand Up @@ -79,6 +79,7 @@ const PRICING_TIERS = [
'Supplier onboarding + FTL scoping',
'CSV upload + API ingestion',
'Self-check scoring + FDA-oriented sortable export workflow',
'EPCIS 2.0 export (Preview)',
Comment thread
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Resolved
'Recall drill workflows',
'Email support',
],
Expand All @@ -96,7 +97,7 @@ const PRICING_TIERS = [
'Everything in Base',
'Multi-facility operations',
'Retailer-specific readiness benchmarks',
'FDA-oriented sortable export + EPCIS 2.0 export (Preview)',
'EPCIS 2.0 export (Preview)',
'Priority email support',
],
},
Expand All @@ -113,6 +114,7 @@ const PRICING_TIERS = [
'Everything in Standard',
'Priority onboarding support',
'Custom integration scoping (per scope of work)',
'EPCIS 2.0 export (Preview)',
'Shared Slack channel (per agreement)',
'Quarterly compliance review (scheduled per agreement)',
],
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6 changes: 4 additions & 2 deletions regengine/client.py
Original file line number Diff line number Diff line change
Expand Up @@ -472,8 +472,10 @@ def export_fda(
"""
Generate FDA-compliant sortable spreadsheet (CSV).

Per 21 CFR 1.1455(b)(3), produces a spreadsheet within 24 hours
containing all traceability records for the specified lot.
Per 21 CFR 1.1455(c)(3), records must be provided within 24 hours of an
FDA request; per 1.1455(c)(3)(ii), they must be in an electronic sortable
spreadsheet. Produces that spreadsheet with all traceability records for
the specified lot.
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Args:
tlc: Traceability Lot Code
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3 changes: 2 additions & 1 deletion services/graph/app/routers/fsma/compliance.py
Original file line number Diff line number Diff line change
Expand Up @@ -107,7 +107,8 @@ async def export_fda_request_sheet(
formatted exactly according to the FDA's Excel template columns:
[Traceability Lot Code, Product, Quantity, Unit, Location, Date, Time, ...]

Required by FSMA 204 Section 1.1455(b)(3) - must be provided within 24 hours.
Required by FSMA 204: 21 CFR 1.1455(c)(3) sets the 24 hour deadline after an
FDA request, and 1.1455(c)(3)(ii) requires the electronic sortable spreadsheet.
"""
logger.info("fda_request_export_initiated", start=start_date, end=end_date)

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