FDA import alerts
A manufacturer on an import alert means detention without examination. Every supplier is checked against FDA's alert lists each morning, weeks before the goods ship.
For pharmaceutical, chemical and life-science importers
Follow each shipment from the supplier's dock to QA release. See the FDA, DEA and customs paperwork each one needs, who owes it and when, before a hold or storage fees cost you.
Octreotide acetate · 0.8 kg · 3 insulated shippers
PharmaCarta marks them on the chart weeks earlier, while a phone call or a corrected document still fixes them.
A manufacturer on an import alert means detention without examination. Every supplier is checked against FDA's alert lists each morning, weeks before the goods ship.
Treasury and Commerce keep adding chemical makers to their lists. Suppliers, brokers and forwarders are checked against them daily, and a possible match waits for your review.
Bulk drugs labeled without the caution statement or country of origin get detained. A photo of the supplier's label is read and checked before the drums are loaded.
Storage and demurrage start the day after free time ends. Each container is counted down, with a warning before it passes.
Form 236, 357 or 486 deadlines are set from the planned sailing date, and move when the sailing moves.
Dangerous goods get their declarations. Products shipped at 2–8 °C get a logger to pack and a log to review on arrival.
Documents
Drop the supplier's paperwork on a shipment. Each document is recognised and filed against its checklist line, and every Certificate of Analysis is checked against the lot it's for: lot number, results against specification, and shelf life left on arrival.
Paperwork
Everything a supplier, broker or forwarder still owes, across every shipment, gathered into one message that's ready to send. Unanswered requests come back for a follow-up after three days.
Quality
Lots that reach the warehouse wait in one QA queue. A lot is released only on a checked and approved CoA, and the record keeps who decided and when, for audits and recalls.
Forms
FDA 766 after a detention, CBP 5106 for your importer number: filled in from the shipment's records, with every value marked as on record, drafted for you to check, or still needed. Each form is checked weekly for a newer version.
Pick the supplier and the products, then paste a container number, bill of lading or air waybill. Typing mistakes in container and air waybill numbers are caught.
Every FDA, CBP, DEA, EPA and dangerous goods item that applies, with an owner, a deadline and the reason it's needed. The supplier is checked against FDA's alerts and the sanctions lists.
Vessel and flight milestones update on their own. A delay moves the deadlines that depend on it.
Record FDA and customs status from your broker, then QA releases each lot. Every lot keeps its paper trail for audits and recalls.
Shipments into the US get FDA, CBP, DEA and EPA items, and every supplier is checked daily against FDA's import alerts and the US sanctions lists. Shipments into Mexico get COFEPRIS permits and the pedimento. Every rule says why it applies and how much lead time it needs, so your broker can check it.
When FDA, a customer's auditor or your own QA asks how a lot was handled, the answer is already written down: what arrived, what was checked, and who decided.
Know where every lot stands before anyone asks.
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