Track every active FDA consent decree and regulatory injunction. The rarest and most severe enforcement tier, joined to the plant entity.
The consent-decree tier is the rarest and most severe FDA enforcement instrument, used when warning letters and import alerts have failed to compel compliance. The catalog currently surfaces two active regulatory injunctions, both issued by ANSM in France against single-site biomedical operators. Historically, FDA consent decrees against pharmaceutical manufacturers have entered at a rate of one to three per year and unwound on a multi-year arc. PharmaDB indexes the active-injunction view and the historical decree archive in a single feed.
Upload or define suppliers. PharmaDB resolves each to its plant entities and corporate parent.
Every active FDA consent decree, regulatory injunction, and court-ordered enforcement event is matched against the resolved list monthly.
Citation-anchored brief with the decree text, the cited reason, the monitoring programme, and the projected dissolution arc.
Active injunctions visible today plus the historical decree archive. The pattern in the archive informs how long the active items typically take to unwind.
Every consent decree is preceded by warning letters and OAI cycles. The brief surfaces the multi-event escalation path so a buyer understands the predictor sequence.
Median time from decree entry to dissolution is three to five years across the historical archive. The projection chip helps a buyer plan around the supplier's recovery window.
A decree against one plant of a multi-plant company is rarely a corporate-wide block. The brief separates plant scope from corporate scope so the response can be calibrated.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Plants currently carrying the consent-decree pre-history pattern · multi-warning-letter and repeat-OAI sequence at the same site · live warehouse.
The consent-decree tracker is the terminal-tier enforcement signal. PharmaDB indexes active injunctions and the historical decree archive, then computes the pre-history pattern (multi-warning-letter plus repeat-OAI) that predicts the next decree. The view is compliance_events filtered to event_type = 'consent_decree'. Refresh cadence is monthly.
A consent decree is a court-ordered agreement between the FDA and a manufacturer that legally binds the firm to a specific compliance programme. It is the agency's strongest enforcement tool short of suspending operations and is typically entered after warning letters and import alerts have failed to produce sustained compliance.
Median active duration in the historical archive is three to five years. Some decrees include independent third-party monitoring, additional inspection cycles, and capital investment milestones. The decree usually dissolves once all monitoring conditions are met.
In France and several EU jurisdictions, ANSM and equivalent agencies use court-ordered injunctions for the same purpose. The instrument is similar; the legal mechanism differs. PharmaDB indexes both under the same enforcement-tier label.
Every historical decree was preceded by at least one warning letter and a repeat-OAI sequence at the same plant. The pre-history pattern is the predictor; the decree is the lagging consequence. The pre-history view above is the active-watch list.
Consent decrees are filed in court and published by FDA litigation announcements. The catalog refreshes monthly because the event rate is low. Each row carries the filing date and the resolution date once dissolved.
Usually it is plant-scope, not corporate-scope. A decree against one fill-finish line at one site does not preclude the manufacturer's other plants from serving an RFQ. The brief separates plant scope from corporate scope so the response can be calibrated.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.