On Jan 22, 2026, Flowchem Pharma landed on FDA's Import Alert 66-40 Red List — its products detained at the US border. The warning letter didn't publish until Mar 11. That ~7-week gap is the product: FlaggedRx is the cross-regulator early-warning feed that tells your Quality team the day a foreign API or CMO supplier is flagged, while the market waits on the press release.
Live coverage across 6 regulator sources in 4 jurisdictions — every flag verified at the source, with provenance and freshness on each record.
Paste a supplier name → every recall, alert, import refusal, and Import Alert 66-40 placement we can find, each with a source link, a freshness date, and a 0–100 risk score.
Add your supplier base to a watchlist. We snapshot, diff, and email you a 🚨 EARLY WARNING the instant a new Red List placement appears. (Slack delivery coming.)
Export the audit CSV — the inspector-ready artifact for your 21 CFR 211 supplier-qualification file, FEI-keyed with provenance.
When a foreign supplier lands on FDA's Import Alert 66-40 Red List, its shipments are detained at the US border without physical exam. The signal exists weeks before the warning letter — it just sits siloed across regulators in incompatible formats. FlaggedRx closes that gap so Quality acts on the border flag, not the press release. We surface flags with provenance and link every one to the authoritative record. A human decides — absence of a flag is never an all-clear.
Real, primary-source-verifiable case: Flowchem Pharma Private Limited (Andhra Pradesh, India). See the 48-day gap measured →
No dashboard-watching. When a supplier you monitor hits the Red List — or gets a recall, warning letter, refusal, MHRA or CDSCO flag — this is the alert, with a link to the source record.
1 new regulatory flag on your watched suppliers — 1 critical.
Decision-support from public regulatory data — not a safety verdict. Absence of a flag is not an all-clear.
Updated from the live FDA Red List. Search any of these to see the full cross-regulator picture.
The hard part isn't fetching data; it's knowing the firm on FDA's Red List is the same one in an MHRA recall and a CDSCO notice, spelled three different ways. FlaggedRx resolves one supplier across transliteration, legal-suffix, and subsidiary variance — "Accord" alone collapses 60+ name variants across FDA and MHRA into a single identity — so a flag filed under a subsidiary or a misspelled legal name still reaches you. We bias toward keeping firms separate over wrongly merging them, and route ambiguous high-severity matches to a human review queue.
Enterprise reg-intelligence platforms are comprehensive and excellent — and quote-only, with 30–90 day procurement. We're complementary: cheap, self-serve, same-day, focused on the one signal your supplier-qualification file lives or dies on. We're additive to your Quality workflow — nothing to rip out.
| Enterprise reg-intel | Waiting for the warning letter | FlaggedRx | |
|---|---|---|---|
| Job to be done | Comprehensive multi-agency database + workflow | — | Supplier-flag early warning + watchlist matching |
| Import Alert 66-40 lead time | Covered | 0 — you learn at publication | ~7 weeks before the letter |
| India / CDSCO NSQ coverage | Varies | — | Included |
| Cross-regulator identity resolution | Yes | — | Yes — on the import-alert blind spot |
| Access | Enterprise quote-only · 30–90 day procurement | Free (but too late) | Self-serve · same-day |
| Price | Quote-only (enterprise) | — | $450–$1,500/mo |
We don't claim to be the only cross-regulator monitor — enterprise platforms do it too. Our edge is CDSCO/India inclusion, identity resolution on the foreign-supplier import-alert blind spot, and self-serve access. Competitor pricing is not public; we show only our own.
Quality, Supplier Quality, and RegOps at US generic and specialty pharma makers — and the CDMOs and importers who answer to them. If your first signal that a sourced site was detained at the US border is the published warning letter, you've already lost the weeks that matter. Start free with a single Supplier Risk Check; upgrade to continuous monitoring and audit exports for your whole supplier list.
Run a free cross-regulator Supplier Risk Check — no login.
Check a supplier ↑Six regulator feeds across four jurisdictions. Source, cadence, and coverage are stated per row — and on every alert. A feed that goes stale or dark degrades loudly on our live source status; it never silently reads as "no flags found."
| Source | What we index | Cadence | Coverage |
|---|---|---|---|
| FDA — Import Alert 66-40 🇺🇸 Red List (DWPE · cGMP drugs) | Foreign firms detained at the US border — the wedge signal. See the searchable Red List → | Continuous · cached ≤12h | All public Red List firms |
| FDA — Warning Letters 🇺🇸 Data Dashboard | Company · issuing office · subject · FEI join key | ~weekly | All public warning letters |
| FDA — Import Refusals 🇺🇸 Data Dashboard | Per-shipment refusals · firm · FEI | ~weekly | All public import refusals |
| FDA — Drug Recalls 🇺🇸 openFDA enforcement | Recalling firm · class · reason | ~weekly | All public US drug recalls |
| MHRA 🇬🇧 GOV.UK | Class 1–4 medicines recalls · firm · action | ~daily | UK medicines safety alerts |
| CDSCO India 🇮🇳 NSQ / spurious | Not-of-standard-quality + spurious-drug alerts · manufacturer — the differentiator | ~monthly | Public NSQ / spurious PDFs |
Live per-source last-checked status and staleness → source status. Not-of-standard-quality is not approval; absence of a flag is never an all-clear.
How we source, label, and scope what we sell — the same rules whether you're a paying customer or just running a free check.
We're a UI on public regulator data, not a proprietary score. Every record links to its originating FDA / MHRA / CDSCO source, with a fetch time and content hash.
Every record carries a last-checked date. A feed that goes stale or dark degrades loudly on /health and in alerts — it never silently reads as "no flags."
We report the presence or absence of a flag — never "this supplier is clean." Absence of a flag is not an all-clear. A human always decides.
Our flags inform your qualification decision. They are not regulatory or legal advice and don't replace your 21 CFR 211 process. See our disclaimer.