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the free, public fda enforcement database

Every FDA enforcement action. Yesterday’s, by 6am.

Warning letters, recalls, approvals, 483s — AI-summarized, cited back to fda.gov, free public database included. 4,064 actions and counting.

Free public database and a free weekly briefing, forever — no card required. Paid plans start at $99/mo and add daily delivery, real-time watchlist alerts, and full search, so a compliance officer reaches Monday’s standup informed, not catching up.

Free public data. AI-native access. Priced for solo compliance officers, not enterprise procurement.

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Free FDA enforcement alerts, matched to your watchlist.

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Argus HQ <signals@argushq.ai>6:00 am ET

sample brief · today’s watchlist match

critical · CDER · WL 320-26-95

Huons Co., Ltd., CGMP / Finished Pharmaceuticals (issued 2026-06-15)

FDA cited Huons Co., Ltd.’s Korean facility (FEI 3007163376) for CGMP violations across 5 subsections of 21 CFR 211 — laboratory records (211.194(a)), microbial contamination control (211.113(b)), production record review (211.192), consultant oversight (211.34), and premises design (211.42(c)). Huons voluntarily recalled facility-manufactured drugs in March 2026, and FDA placed the company on Import Alert 66-40 (imposed 2026-04-03), blocking further imports pending verified corrective action.

Why this matched: finished pharmaceuticals, foreign CDMO oversight, lab data integrity

See the full brief with all matched letters ↓

Real Argus brief, condensed. Verbatim from FDA.gov, Warning Letter issued 2026-06-15.

Live feed · Updated 2026-08-13 14:27 UTC

AAL Trading Inc.2026-07-15
The FDA issued a warning letter to AAL Trading Inc. (Linden, NJ) on July 15, 2026, follow…
Koven Technologies, Inc.2026-07-21
# FDA Warning Letter Summary **FDA, Center for Devices and Radiological Health** issued a…
Maria E. De La Torre Silva, M.D.2026-07-27
The FDA Center for Drug Evaluation and Research (CDER) issued a warning letter dated July…
Friend’s Stable and Orchard, Inc.2026-07-14
The FDA issued a warning letter (CMS #728680) to Friend's Stable and Orchard, Inc. on Jul…
ABS Corporation2026-07-23
The FDA Center for Veterinary Medicine issued a warning letter to ABS Corporation (7031 N…
Woodbine Products Company Inc.2026-07-27
The FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter to Woodb…
Dabur India Limited2026-07-24
FDA Center for Drug Evaluation and Research (CDER) issued Warning Letter 320-26-105 to Da…
Thomas Brunner Hygiene GmbH2026-07-24
The FDA Center for Drug Evaluation and Research issued a Warning Letter (Reference 320-26…
Prida Import & Export LLC2026-04-10
The FDA issued a warning letter to Prida Import & Export LLC (CEO Daniel Moussa, Doral, F…
San Jorge Produce LLC2026-07-16
The FDA issued a warning letter (CMS #734097) to San Jorge Produce LLC on July 16, 2026,…
Piquin Y Sabores Distributors LLC2026-07-02
On July 2, 2026, the FDA issued a warning letter to Piquin Y Sabores Distributors LLC (ow…
Delight Distribution Inc.2026-06-08
The FDA's Office of Inspections and Investigations issued a warning letter to Delight Dis…
Source · fda.gov public recordAI · Anthropic ClaudeDelivery · Resend, 6am ET dailyBilling · Stripe-secured · cancel one clickHosting · Vercel · Supabase

four signals, one brief

Warning Letters, 483 observations, recalls, and approvals, matched to your watchlist.

Warning Letters are still the core of Argus, the highest-signal enforcement document FDA publishes, and the reason compliance teams subscribe. The three signals around it close the gaps a Warning-Letter-only feed leaves open.

core · launched

Warning Letters

CGMP violations, drug quality failures, remediation demands, the document that starts the clock on every serious FDA enforcement action.

483 observations

483 Observations

Inspection findings, issued 6–18 months before the Warning Letter that follows. See the early signal, not just the escalation.

recalls

Recalls

Class I/II/III drug and device recalls, matched to your watchlist the same day they post.

approvals

Approvals

Competitor NDA/BLA approvals, so a competitive market event never reaches you secondhand.

why now

FDA is issuing more Warning Letters with fewer people watching them, on both sides of the inbox.

Three verifiable data points explain why manual FDA monitoring is getting harder to sustain right now, not just an abstract argument for “better tools.”

+50-59%

FDA issued 303 drug and biologics Warning Letters in FY2025, up from 190 in FY2024, a 59% jump. A senior FDA official told regulatory press CDER’s own count rose roughly 50%. The pace held into 2026: CDER added ~30 more letters by March and ~25 more by mid-June.

RAPS, Dec 2025: “FDA official: CDER warning letters up 50% in FY 2025.”

~3,859 cut

FDA lost roughly 3,859 staff in 2025 amid HHS/DOGE-driven restructuring. Separated inspectors averaged 19 years of experience, institutional knowledge that doesn’t come back with a headcount refill.

ProPublica & Morgan Lewis client alert, 2025-2026 reporting on FDA workforce reductions.

14,180+ jobs

Pharma and biotech companies cut over 14,180 jobs across 25+ companies in the first half of 2026 alone. Quality and compliance headcount hasn’t been spared. Novo Nordisk’s cuts, for one, included quality-control staff.

Industry layoff trackers & PharmaVoice reporting, H1 2026.

More enforcement, fewer people tracking it, at FDA and inside compliance teams. That gap is what Argus is built to close. Read the full analysis →

before you ask

Three things every compliance lead asks before they sign up.

“I already use Bloomberg / Veeva / Sparta.”

Those solve a different problem at a different price. Bloomberg Gov / FDAnews seat pricing runs roughly $1,500–$2,500/mo per published industry surveys, broad federal regulatory monitoring, not FDA-specific triage. Veeva Vault QMS starts around $25k/yr in base licensing plus per-user fees; Sparta/TrackWise is custom-quoted and not publicly priced. Both are enterprise quality-management systems, not a daily brief. None of them narrowly track FDA Warning Letters the way Argus does. Argus plans start at $99/mo and run as an add-on most teams run alongside those systems, not instead of them.

“AI-generated summaries might be wrong.”

Occasionally, yes. That’s why every summary is informational only, brand-voice lint-checked before send, and shipped with the verbatim fda.gov source URL on the same line, so you can verify the summary against the primary record in seconds, not the ninety minutes it takes to find that letter yourself.

“This needs procurement approval at my company.”

For most teams it won’t clear a procurement threshold at all. Plans start at $99/mo (Starter) and top out at $399/mo (Team); every tier is a month-to-month Stripe subscription with no annual contract, no per-seat licensing, and a 30-day money-back guarantee. Most compliance leads expense the Starter tier directly, the same way they’d expense any other sub-$200 SaaS tool — and Starter is $99.

Bloomberg Gov / FDAnews and Veeva pricing are third-party industry estimates, not vendor-published rate cards. See the full comparison below for sourcing detail.

inside today’s brief

One curated intelligence artifact a day. Trends, repeat offenders, watchlist matches.

Every weekday morning the brief lands at 6am ET. It opens with a trend pulse on the week’s Warning-Letter volume and the issuing office driving it, then surfaces each matched letter as its own section, severity, citation, 150-word AI summary, and a verbatim link back to fda.gov. Entities you already monitor that get cited a second time are flagged as repeat offenders.

  • 01

    Trend pulse. Brief opens with the week’s Warning-Letter volume, the month-over-month delta, and the issuing office (CDER / CDRH / CBER / CFSAN / CTP) driving it. Context before content.

  • 02

    Repeat-offender flag. If an entity on your watchlist was cited before in the past 24 months, the new letter ships with a “Previously cited” tag and the prior date.

  • 03

    Severity + citation block. Color-coded severity, issuing office, 21 CFR references called out, response window stated explicitly. The triage layer your QSR review needs.

  • 04

    AI summary, 150 words. What FDA found. What it cites. What the response window is. Brand-voice lint-checked before send; falls back to a deterministic summary on drift.

  • 05

    Why this matched. Plain-English line per item naming the watchlist token that caught it, a CDMO, a competitor, a therapeutic area. Decision-support, not a feed.

  • 06

    Friday executive briefing. One PDF every Friday: the week summarized for your leadership. Email it forward. It’s the audit-ready artifact your quality system keeps.

what isn’t in the brief

No signal outside your watchlist. No noise from enforcement activity that doesn’t touch your business. No daily “here’s what’s happening in healthcare” recap. If FDA publishes nothing relevant to you on a given day, you get no email.

from Argus HQ <signals@argushq.ai>·tue, jun 29 · 6:00 am
trendTrend pulse: 10 new FDA Warning Letters posted 2026-06-23 · CDER leads (8) · CGMP citations dominant.

argus.hq, daily brief

3 watchlist-matched letters for 2026-06-23.

Matched against finished-pharma + foreign-facility watchlist · 2 critical, 1 medium.

critical · CDER · WL 320-26-95Foreign facility · 5 CFR refs

Huons Co., Ltd., CGMP / Finished Pharmaceuticals / Adulterated (issued 2026-06-15)

FDA inspected Huons Co., Ltd.’s drug manufacturing facility (FEI 3007163376, Jecheon, Chungcheongbuk, Korea) from November 12–21, 2025 and documented CGMP violations under 21 CFR 211.194(a), 211.113(b), 211.192, 211.34, and 211.42(c) — spanning lab record integrity, microbial contamination control, production record review, consultant oversight, and design/construction of manufacturing premises. FDA flagged the need for third-party assistance in remediation and warned of injunction/import alert if violations recur.

Read the full letter on fda.gov →

Why this matched your watchlist: finished pharmaceuticals, foreign CDMO oversight, lab data integrity

critical · OII · FSVP

Vivot LLC — Foreign Supplier Verification Program (posted 2026-06-23)

Office of Inspections and Investigations cited Vivot LLC for failing to develop, maintain, and follow FSVPs for imported foods under 21 CFR Part 1, Subpart L. A pattern citation if you import ingredients — OII has issued 4 FSVP letters in the last 6 weeks, all centered on supplier-verification documentation gaps.

Read the full record on Argus HQ →

Why this matched your watchlist: imported ingredients, FSVP compliance

medium · Human Foods Program

Imu-Tek Animal Health, Incorporated — Dietary Supplement / New Drug / Misbranded (posted 2026-06-23)

Human Foods Program cited Imu-Tek for marketing products that meet the “new drug” definition under 21 USC 321(p) without an approved application, and for labeling that classifies them as dietary supplements while making disease claims. Pattern note: 6 of 10 letters this week center on unapproved drug / misbranded labeling — CDER pursuing online sellers aggressively in Q2.

Read the full record on Argus HQ →

Why this matched your watchlist: animal health products, labeling/marketing claims

Know a regulatory leader who’d find this useful? Forward this email — they can join the watchlist at argushq.ai.

Argus HQ is informational only. Summaries are AI-generated and may contain errors. Always verify against the FDA source link before acting. Not legal, financial, or medical advice.

Edit watchlist · Manage subscription · Unsubscribe

Real Argus brief. All three letters here are verbatim from FDA.gov, posted on 2026-06-23. Your daily brief is built from your own watchlist.

morning ritual, not another dashboard

No logins. No training. No dashboards to check.

Argus lands in the inbox where compliance officers already work. Six AM Eastern, weekdays. Two-minute read. Match your watchlist. Ready to forward to leadership.

Compliance teams don’t need another SaaS to open. They need one email that tells them what changed overnight.

how it works

Intelligence delivered to your inbox. Three steps. Two minutes.

01

Subscribe

Start free, or pick a paid plan from $99/month. No setup fee, no sales call, no seat math. Your Enforcement Intelligence access is provisioned automatically.

02

Tell us what to watch

Three short questions, ninety seconds: your industries, the CDMOs you depend on, the competitors you watch. Skip and you receive every FDA Warning Letter until you set preferences.

03

Read the daily brief; archive the Friday briefing

At 6am ET the brief lands: trends, repeat-offender flags, and watchlist-matched letters with source citations. Friday adds the executive briefing PDF, the audit-ready artifact your quality system keeps.

cost of monitoring

From $99/mo vs $24k/yr Bloomberg Government.

Most mid-market biotechs and device companies pay one of three prices for FDA monitoring. Two of them are wildly out of proportion to what gets used.

Comparison featureArgus HQBloomberg Gov / FDAnewsDIY internal scrape
Monthly cost$99–$399$1,500–$2,500 / seat$0 + 4–8 analyst hours/wk
ScopeWarning Letters, 483s, recalls, approvalsFederal-wide regulatory monitoringWhatever the analyst remembers to check
Filtered to your businessYes, your watchlistManual saved searchesManual judgement
Delivery latencySame-day publish → next 6am ETVariable; depends on UI useWhen the analyst gets to it
Source-linked citationsVerbatim fda.gov URL on every lineYesIf the analyst captured it
Seat licensingNone, share inbox internallyPer-seatN/A
CancelOne click, Stripe portalAnnual contractN/A

Bloomberg Government and FDAnews pricing per published 2025 industry surveys; figures are indicative ranges, not exact quotes. DIY hours are typical compliance-team estimates.

vs FDAzilla / Redica Systems

From $99/mo vs a ~$5k–$8k/yr enterprise contract.

Redica Systems (FDAzilla) covers far more than Warning Letters, 483s, inspections, cross-agency data. If all you need is a daily, watchlist-matched Warning Letter brief, here’s what that costs on each side.

Comparison featureArgus HQFDAzilla / Redica SystemsManual monitoring
Price$99–$399/mo~$5k–$8k/yr contract$0 + ~10 hrs/wk
Contract lengthMonth-to-monthAnnual, procurement reviewN/A
CancelOne click, 30-day guaranteeLocked for termN/A
Setup time< 15 minutesWeeksNone, but ongoing labor

Redica Systems does not publish pricing; the $5k–$8k/yr figure is an industry estimate, not a vendor quote. Read the full row-by-row comparison →

speed

5 min

to scan the brief. fda.gov publishes Warning Letters as individual HTML pages without industry or therapeutic-area filtering.

Same-day publish → next 6am ET delivery target. Median brief: 280 words across two to four letters.

scope

300+ / yr

FDA Warning Letters published, every one ingested.

Each Letter matched against your watchlist before delivery. Only the ones that touch your business reach your inbox.

cost

$99 / mo

plans start here, no per-seat licensing, cancel any time.

Forward the brief inside your team. Argus is priced as a publication, not as enterprise software.

who argus is for

Four roles where FDA Enforcement Intelligence pays for itself in one quarter.

Compliance Officers

Mid-market biotech, pharma, and medtech (50–500 employees). You own the answer when the CEO asks about a competitor Warning Letter. Argus is the workflow that gets you there first.

Heads of Quality / Regulatory Affairs

You triage CGMP/QSR findings against your own systems weekly. Repeat-offender flags on your CDMO list and the Friday briefing become the audit-ready record your quality system keeps.

In-house Counsel + GRC

You sit across compliance, legal, and risk. The trend pulse, citation block, and exportable audit trail give you defensible documentation without standing up another monitoring vendor.

Consultants

Independent FDA consultants, fractional QA leaders, regulatory-affairs advisors. Stop pulling fda.gov daily for each client. Argus delivers the watchlist-matched intelligence and the Friday briefing you can hand to a client as your own deliverable.

pricing

Free public database and briefing, forever. Paid plans from $99/mo.

Free tells you what happened last week. Paid tells you today — daily delivery, real-time watchlist alerts, and full search.

Free

$0

Full public database, weekly briefing, forever.

Starter

$99/mo

Daily delivery, all four FDA streams, CSV export.

Standard

$199/mo

Real-time watchlist alerts, Friday executive briefing.

Team

$399/mo

Multi-seat, invoicing, priority support.

Compare all plans & start free30-day money-back guarantee. No forms. No sales call. Cancel in one click — refunded fast.

the database · verify our claims

Argus is watching FDA in real time.

Every letter is matched to your watchlist automatically. Every summary is sourced. Every citation is verifiable at fda.gov. Every number below links to the page that proves it.

210

FDA Warning Letters indexed and summarized

3,510

FDA recalls indexed

158

FDA drug approvals indexed

186

Form 483 inspection observations indexed

825

companies with an FDA compliance flag on record

Browse the full database →·See coverage & date ranges →·Read our methodology →

faq

The questions compliance officers actually ask.

How is this different from just reading fda.gov?

fda.gov is the public record. It is not the workflow. Argus is the intelligence layer on top: a watchlist filter so you read only the letters that touch your business, trend pulse on weekly volume + issuing-office mix, repeat-offender flagging on entities you already monitor, and a Friday executive briefing PDF that becomes the audit-ready artifact your quality system keeps. fda.gov is the source. Argus is the workflow tool, decision-support layer, and forward-safe deliverable. Both have their place; the daily 90-minute fda.gov scrape does not.

Is this legal advice?

No. Argus surfaces public FDA Warning Letters and adds an AI-generated summary so your team can triage faster. Every decision on those records belongs with you and your counsel. Each section links the verbatim FDA source URL. Always read the original before acting.

What sources does Argus cover?

Argus tracks four FDA enforcement signals: Warning Letters (the highest-signal regulatory document FDA publishes, and the core of Argus), 483 inspection observations (issued 6–18 months before the Warning Letter that often follows), Class I/II/III drug and device recalls, and competitor NDA/BLA approvals. All four are matched to your watchlist. SEC EDGAR, CPSC recalls, USDA FSIS, NHTSA, and the Federal Register are on the roadmap. We add sources based on what paying customers tell us they need next, not on a guessed roadmap.

How accurate are the AI summaries?

Summaries are produced by Anthropic Claude Haiku 4.5 and brand-voice lint-checked before send. They are informational only. They may contain errors, mis-classify the severity, or omit a citation. Argus is built to be a triage aid, not the regulatory record. The verbatim FDA URL is on every section so you can verify before acting.

How is “watchlist matching” implemented?

At signup you answer three questions: your industries, the CDMOs you depend on, and the competitors you watch. Each Warning Letter ingested is matched against those tokens (case-insensitive substring on title, summary, company name, and any aliases we know about). Skip the survey and you receive every Warning Letter until you set preferences.

Can I cancel?

Yes, any time, from the Stripe billing portal at /settings. At most one alternative offer, then your cancellation takes effect — no phone calls. The current period is pro-rated on cancellation; you keep access through the paid-through date.

Can I forward the brief inside my team?

Yes. Argus is priced as a publication, not as enterprise software. There are no per-seat licenses. Forward the daily brief to whoever needs it on your quality, regulatory, or compliance team. Multi-seat / SSO / API tiers land in V2.

Where does the data come from?

Argus reads the public FDA Warning Letters listing at fda.gov and the per-letter detail pages. US government works are public domain under 17 USC §105; we re-display them with attribution and a direct link back to the original record.

Will Argus ever email me on a day with no relevant letters?

No. The brief is only sent when at least one Warning Letter matches your watchlist that day. On quiet days you get an empty inbox, not a “here’s nothing” email.

Stop reading FDA enforcement six weeks late in a trade-press round-up.

Free public database and weekly briefing, forever. Paid plans from $99/mo add daily delivery and real-time alerts. Two minutes to set up. Cancel any time.

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