What companies just did with the FDA, every Monday
A 510(k) clearance, a new device or drug listing, a recall or a warning letter is a company that needs help now: manufacturing, sterilization, distribution, quality or regulatory work. Every Monday we send you the new ones in the topics you pick, with a CSV.
- Five FDA topicsClearances to warning letters
- Every MondayNew since last week
- Email + spreadsheetCompany, product, class
- Eurofins SF Analytical…Warning letter · New Berlin, WIOct 13
- Todd's Seeds LLCRecall · Cookeville, TNOct 7
- Roche DiagnosticsClearance · Indianapolis, INOct 2
- Guangdong Youmeng Electrical…Device listing · Foshan Guangdong, ChinaSep 30
- Aurobindo Pharma LimitedDrug listing · Prescription drugOct 16
Built for companies that sell to FDA-regulated firms
Regulatory and quality consultants
A warning letter or a Class I recall means a remediation project; a new clearance means a QMS to build.
Start with warning letters →Contract manufacturers and sterilizers
Newly cleared devices and new listings are companies choosing manufacturing, sterilization and packaging partners.
Start with clearances →Distributors and recall services
New device and drug listings need distribution; recalls need logistics, notification and destruction.
Start with recalls →About 380 company events a week
Events per week over the last 4 full weeks each source has published. One event is one company doing one thing: a listing event can cover several products.
| Topic | A week | US companies | What each event has |
|---|---|---|---|
| Warning letters Companies FDA just warned | 15 | 13 | Company, subject, issuing office, address |
| Recalls Food, drug and device recalls | 37 | 32 | Firm, product, class, reason, distribution |
| Device clearances and approvals 510(k), De Novo and new PMA approvals | 63 | 29 | Company, device, product code, specialty, 510(k)/PMA number |
| New device listings Establishments listing new devices | 179 | 72 | Establishment, type (CMO, sterilizer…), devices, address |
| New drug listings (NDC) Labelers listing new drug products | 87 | — | Labeler, products, NDCs, dosage form |
FDA loads 510(k) decisions and device listings about a week after the decision, and posts warning letters weeks after they're issued, so each event reaches you the first Monday after FDA publishes it. FDA Activity Weekly is independent and not affiliated with the FDA.
This month's FDA activity
The latest clearances, listings, recalls and warning letters, with weekly counts.
What lands in your inbox
Real events from recent weeks. Every email attaches all your matches as a spreadsheet.
New FDA activity this week
Your topics and filters · since last Monday
- Warning letter · CDEREurofins SF Analytical Laboratories, Inc.CGMP/Finished Pharmaceuticals/Adulterated · New Berlin, WIOct 13posted
- Food recall · Class ITodd's Seeds LLCTodd's Seeds Salad Sprouting Mixture - Broccoli, Mustard, Alfalfa and Cabbage, packaged in heat-sealed… · Cookeville, TNOct 7reported
- 510(k) · Class IRoche DiagnosticsElecsys EBV VCA IgG · Indianapolis, INOct 2decision
- Device listing · Class IIGuangdong Youmeng Electrical Technology Co., LTD.Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62);; Philips… · Foshan Guangdong, ChinaSep 30listed
- Drug listing · Prescription drugAurobindo Pharma LimitedOxcarbazepine; Oxcarbazepine; OxcarbazepineOct 16first seen
- Device recall · Class IIASP Global, LLC.Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE… · Austell, GAOct 7reported
Build your alert
Pick your topics, then narrow by place, recall type and class, device specialty and establishment type. One email every Monday.
Alerts go to the email you enter at checkout: the last 14 days within the hour, then every Monday morning. By purchasing you agree to the Terms and Data Use Policy. Already a customer? Manage or cancel.
Questions
Can't find what you need? Email support@sabrsoftware.com and a person answers. Sources: U.S. Food and Drug Administration records (openFDA and FDA warning letters).
Where does the data come from?
Public U.S. Food and Drug Administration records: openFDA's 510(k), PMA, device registration and listing, NDC directory and enforcement report data, and FDA's warning-letter pages. FDA data is in the public domain, and openFDA publishes it under a CC0 dedication, free to reuse. We aren't affiliated with or endorsed by the FDA.
What counts as new?
A 510(k) clearance or De Novo grant, or an original PMA approval (supplements are left out); a device listing created that week; a product NDC that wasn't in FDA's drug directory the week before; a recall in that week's enforcement report; and a warning letter FDA just posted. Each event comes once, the first Monday after FDA publishes it.
Why are some events a week or more old?
FDA publishes 510(k) decisions and device listings about a week after they happen and posts warning letters weeks after they're issued. The date on each event is FDA's own (decision, listing, report or posting date).
Do you include contact names?
No. 510(k)s name a contact person, registrations name an official correspondent, and warning letters are addressed to a person; we never include any of them. Letters to individual clinical investigators and companies named after a person are left out.
Which filters apply to what?
Location applies to every topic except drug listings, which carry no address. Recall type and class apply to recalls; device specialty to clearances and device listings; establishment type to device listings.
Can I change my topics or filters?
Yes. Reply to any email with the topics and filters you want.
Can I use the data for screening or credit decisions?
No. We aren't a consumer reporting agency, and the data can't be used for credit, insurance, employment or housing decisions about anyone.
How do I cancel?
Anytime, from the link in every email. Cancellation takes effect at the end of the month you've paid for.