Turn an FDA detention notice into an organized evidence package before the respond-by deadline.
When an FDA-regulated shipment is detained, response procedures require exact testimony and documentation within strict procedural windows. DetentionCase reconciles scattered bills of lading, foreign facility registrations, commercial invoices, and lab certificates into an indexed, discrepancy-checked package ready for your licensed broker to review and submit through ITACS.
Maps procedure windows (typically 10 business days / ~20 calendar days) directly against document procurement lead times.
Breaks down FDA charges (e.g. 801a3 adulteration, misbranding) into explicit evidence requirements per line item.
Identifies name, lot, and registration discrepancies between CBP entry summaries, supplier invoices, and FDA FEI records.
Zero email attachments. Private encrypted bucket per case with guaranteed 30-day automatic data purge.
Evidence Reconciliation Workbench
Below is an anonymized sample of the discrepancy analysis delivered to your compliance desk within 24 hours of notice upload.
Recommended Broker Action: Submit a signed manufacturer declaration of corporate identity or updated FDA-2656 prior to submitting testimony. Submitting conflicting entity names guarantees testimony rejection.
CBP Form 7501 indicates entry includes Lot #2026-X9 (1,200 cartons). The uploaded third-party lab documentation only covers Lot #2026-X8.
Recommended Broker Action: Request lab release for Lot #2026-X9 from importer before filing ITACS package.
Prior Notice PN-82019 exactly matches Bill of Lading container counts, FDA product code (72B--01), and consignee tax identifier.
How DetentionCase operates alongside your brokerage.
We operate strictly as your background evidence-preparation desk. Your staff handles client and officer relations; we handle the document reconciliation.
Notice Intake
Upload the Notice of FDA Action. We parse the cited charges, statutory sections, officer details, and official Respond-By date.
Evidence Mapping
We ingest supplier invoices, packing lists, labels, and lab reports, mapping each document directly to the relevant FDA charge.
Contradiction Check
We cross-check entity names, lot numbers, registration numbers, and dates to identify internal contradictions before submission.
Broker Package
You receive an indexed review packet formatted for immediate professional review and submission through ITACS.
Zero email attachments. Isolated case handling.
We understand that commercial invoices and laboratory assays contain critical trade secrets. Every case is processed inside an isolated, encrypted workspace and automatically purged 30 days after review delivery.
Straightforward per-case pricing.
No software implementation, no seat licenses, and no ITACS credentials required. You send the documents; we deliver the review package.
FDA Detention Evidence Readiness Review
Turnaround: Guaranteed within 24 hours
No credit card required upfront. Invoiced upon delivery of the review package.