How to search FDA warning letters for medical device companies

An FDA warning letter is a letter the FDA sends when it finds what it believes are significant violations of the law. The FDA posts warning letters in a searchable database on fda.gov. To see letters sent to medical device companies, filter the issuing office to the Center for Devices and Radiological Health (CDRH).

For medtech business development and sales professionals at firms that sell services to medical device companies. Whimbrel works inside the AI app you already use, like ChatGPT or Claude.

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What an FDA warning letter is

The FDA sends a warning letter when the agency finds what it believes are significant violations of federal rules. The letter names the concerns. Examples are poor manufacturing practices or wrong claims about what a product can do. The letter asks the company to respond by a set time. The company can send a plan to fix the problems, or explain why it disagrees. Later contact between the FDA and the company can change the status of the issues. Source: FDA, About Warning and Close-Out Letters.

A warning letter is a public record about a company's compliance.

How to search the FDA warning letter database, step by step

Open the FDA Warning Letters page.
Type a company name in the search box to find letters for one company.
For more filters, open the advanced search.
Pick an issue date range if you want letters from a set time.
Pick the issuing office, or type words from the subject.
Choose whether to show letters with a posted response or close-out letter.
Click a company name to read the full letter.

How to see only medical device warning letters

The FDA table mixes letters from every FDA center, like drugs, food and tobacco. To see device letters only, set the issuing office to the Center for Devices and Radiological Health (CDRH). Subjects on device letters often look like "CGMP/QSR/Medical Devices/Adulterated." That subject means the FDA found problems with how devices are made or checked for quality.

Warning letter, Form 483 and close-out letter: what is the difference?

A Form 483 lists what an FDA investigator saw at the end of an inspection. A warning letter is a separate letter. The FDA sends one when the agency finds significant violations, often after an inspection. A close-out letter comes after the FDA checks the company's fixes and finds them adequate. The FDA usually confirms fixes with a follow-up inspection. Sources: CDRH Transparency: Compliance and Enforcement and FDA, About Warning and Close-Out Letters.

Device recalls sit in a different place. The CDRH Transparency page links to the FDA medical device recall database.

How to download the list

The FDA lets you export the posted list of warning letters to a spreadsheet. The list shows the company, the date, the issuing office, the subject, and whether a response or close-out letter is posted. Source: FDA, Warning Letters.

Where the warning letter database falls short for sales research

The FDA table mixes every FDA center. The table shows one kind of record. A warning letter does not tell you what the company makes or what stage the company is at. The letter does not show the company's 510(k) clearances, device trials or funding. Recalls and inspections sit in other FDA databases. To get the full picture, you end up with many tabs open.

Get back the hours you spend researching medtech device companies.

Ask about a company in ChatGPT or Claude with Whimbrel

Whimbrel works inside ChatGPT or Claude. Ask about one US device company in plain words. Whimbrel gives you the company rundown: what the company makes, the company's stage and location, and the events on file. Those events can include 510(k) clearances, approvals, inspections, recalls, CDRH warning letters, trials, grants, funding and news. Each event shows its date and a link to the public source. Whimbrel's warning letters come from the FDA's own warning letter page, and only letters from CDRH are kept.

Here are questions you can ask:

"Tell me about Ostlehurst Medical (Example). Does Whimbrel have any warning letters, recalls or inspections on file?"

"What else is on file for Ostlehurst Medical (Example)? Any 510(k) clearances, trials or funding?"

"Where does Whimbrel's data come from?"

Example

The company: Ostlehurst Medical (Example), a US maker of infusion pumps on Whimbrel's list.

What is on file: The FDA sent the company a warning letter. Whimbrel also has an FDA inspection and a 510(k) clearance on file for the company.

Sources: Each event shows its date and a link to the public record on fda.gov.

Made-up example company; the signal types are real.

Whimbrel helps regulatory consulting firms, testing labs, sterilization firms and contract manufacturers. See all features, or read how Whimbrel works.

Pricing

Whimbrel costs $99 a month for one person, or $948 if you pay for a year. Teams pay $79 a seat a month. Your first month is free on both plans. Whimbrel covers US medical device companies. See pricing for the details.

FAQ

What is an FDA warning letter?

A warning letter is a letter the FDA sends when it finds what it believes are significant violations of the law. The letter asks the company to respond and fix the problems.

How do I find warning letters for medical device companies?

Search the FDA Warning Letters database. Then set the issuing office to the Center for Devices and Radiological Health (CDRH).

Is a warning letter the same as a Form 483?

No. A Form 483 lists what an investigator saw during an inspection. A warning letter is a separate letter about significant violations.

What is a close-out letter?

The FDA sends a close-out letter after the agency finds that the company's fixes for a warning letter are adequate.

Can I download FDA warning letters?

Yes. The FDA says the posted list can be exported to a spreadsheet.

Can Whimbrel show warning letters for a company?

Yes. Ask Whimbrel about one company. The rundown can include CDRH warning letters on file, next to the company's other FDA events, each with a date and a source link.

Which companies does Whimbrel cover?

Whimbrel covers US medical device companies and their suppliers.

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