Screen every supplier and plant against the FDA's active import-alert lists. 66-40, 66-41, and other detention orders resolved to the plant entity, refreshed weekly.
The FDA has issued 341 active import alerts against pharmaceutical plants in the catalog. The 66-40 list (drug GMP failure) carries 110 plants; 66-41 (unapproved new drug promotion) carries 129; the residual 102 fall under specialised detention orders. Indian API sites dominate the recent 66-40 cohort. Each match is resolved to a plant entity and joined to active enforcement chips, so a supplier on a buyer's list surfaces with detention status before the next RFQ.
Upload or define your supplier base. PharmaDB resolves each supplier to its plant entities and FEI identifiers.
Every FDA import alert (66-40, 66-41, other) is matched against the resolved plant list weekly. New listings surface as notifications; delistings flip status to inactive.
Citation-anchored brief with the listing date, the cited reason, and a chip showing whether the plant is also under a warning letter or recent OAI inspection.
Every active 66-40 / 66-41 / other detention order resolved to the plant entity. If a supplier is in DWPE, you see it before commercial terms move.
New listings appear within days of FDA publication; delistings flip the chip to inactive on the next refresh. Stale, manually-maintained spreadsheets miss both.
An import alert rarely arrives alone. The dossier overlays warning letters, OAI inspections, and recall events at the same plant so the severity picture is complete.
The FDA OASIS detention order feed and the public import-alert list are pulled weekly. Active status is point-in-time and citation-anchored.
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pharmagraph_query Twelve plants with an active FDA import alert · most-recent listing date and overlaid inspection class.
The import alert screen is the border-level enforcement signal on top of the warning-letter monitor. PharmaDB resolves every active FDA import alert to its plant entity, then matches against a buyer’s supplier list weekly. The view is compliance_events filtered to event_type LIKE 'import_alert%'; the join is to plants. Refresh cadence is weekly.
IA 66-40 is Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. It is the FDA's strongest border-level enforcement tool against plants that have failed GMP inspection. Listed plants must petition to remove their products from automatic detention at the port of entry.
66-40 targets plants with confirmed GMP failures. 66-41 targets firms promoting unapproved new drugs into the US market. The two lists rarely overlap but use the same DWPE (Detention Without Physical Examination) mechanism. PharmaDB labels each match by sub-list so the response can match the regulatory reason.
By petitioning the FDA after demonstrating that the underlying GMP or compliance issue is resolved. The agency may require a successful follow-up inspection, third-party audit evidence, and a CAPA file. Median active duration in the catalog is wide; the headline is years, not months.
The FDA's public import-alert reference page is pulled weekly. New listings typically appear within days of FDA publication; delistings flip status to inactive on the next refresh. Each row carries the listing and delisting dates.
The companion analysis covers MHRA detention notices, EMA non-compliance reports, EDQM CEP suspensions, and WHO PQ withdrawals. Cross-regulator detention views surface in a separate compliance dossier joinable to the same supplier list.
Yes. The source taxonomy is the FDA's; OTC, compounding, and contract-manufacturing sites are all included. The brief carries the FDA programme so a buyer can filter to API-relevant matches.
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