The FDA warning letter database is the searchable table of warning letters on fda.gov. To search it, open the Warning Letters page, type the company name or FEI number in the search box, then narrow by issuing office, subject and letter issue date. Each row links to the full letter and, when FDA has posted one, the company's response and a closeout letter.
That finds the letter. It does not tell you what happened before it. A warning letter almost always follows an inspection that ended with a Form 483, and often a run of earlier 483s citing the same regulation. The second half of this guide shows how to trace a letter back to that record, using four facilities whose inspection histories in the Atlas directory show a warning-letter outcome.
How do you search FDA's warning letter database, step by step?
- Open the page. Go to the FDA Warning Letters page. The table lists one letter per row with posted date, letter issue date, company name, issuing office, subject, and columns for a response letter and a closeout letter.
- Search the company name, then the FEI. The free-text box matches company names and letter text. Company names vary between letters (a parent name in one, a subsidiary or "dba" name in another), so if the name search is thin, search the FEI number, which appears in the body of most manufacturing letters.
- Filter by issuing office. This is the fastest way to cut noise. CDER covers drug manufacturing and marketing, CDRH covers devices, CBER covers biologics, the foods program covers food and supplements, and the Center for Tobacco Products covers tobacco. Tobacco retailer letters are a large share of the table, so excluding them first makes everything else easier to read.
- Filter by subject. The subject line is FDA's short label for the violation type, for example "CGMP/Finished Pharmaceuticals/Adulterated" or "CGMP/QSR/Medical Devices/Adulterated". Filtering by subject is how you pull every drug CGMP letter in a year without reading tobacco and marketing letters.
- Set the date range on letter issue date, not posted date. FDA often posts a letter weeks after it is issued. For trend work, the issue date is the one that matches the inspection timeline.
- Check the closeout and response columns. A closeout letter means FDA has verified the corrections and closed the letter. A response letter is posted only when the company asks for it. A letter with no closeout years later is still open, which matters if you are qualifying that supplier.
- Export. The table can be exported to a spreadsheet, which is the practical way to count letters by office or subject over a period.
Three limits to plan around. The database is letter text only: it does not show the Form 483 or the inspection classification. It does not list the investigators. And it has no field for CFR sections, so finding every letter that cites 21 CFR 211.192 means searching the text and reading the results.
What does an FDA warning letter contain?
Most manufacturing letters follow the same layout, and knowing it makes them quicker to read:
| Part of the letter | What it tells you | Where it helps |
|---|---|---|
| Header | Date, reference number, recipient, delivery method | CDER manufacturing letters carry a 320- reference; use it to cite the letter |
| Opening paragraph | Facility address, FEI number, inspection dates | The link to the inspection and Form 483 |
| Violations | Each one quoted against a CFR section, then FDA's comments on the company's 483 response | Shows which observations FDA escalated and why the response failed |
| Requests | Retrospective reviews, risk assessments, CAPA, often a qualified consultant under 21 CFR 211.34 | Tells you the scope of remediation FDA expects |
| Conclusion | 15 working days to respond; possible withholding of approvals, import alert for foreign facilities | The consequences that follow if the response falls short |
The violations section is the useful part. FDA usually quotes the regulation, describes what the investigator found, and then evaluates the company's 483 response line by line. When FDA writes that a response was "inadequate", it states what was missing. That paragraph is the best guide there is to what FDA expects in a 483 response, which our guide on how to address and prevent Form 483 observations covers in detail.
How do you trace a warning letter back to its Form 483?
Almost every manufacturing warning letter names the inspection it came from. The steps:
- Take the FEI and inspection dates from the letter's opening paragraph.
- Look up the facility by name or FEI in the FDA facility lookup. Atlas holds 232,103 facilities and 148,507 inspections that ended with a Form 483, with observation-level detail on 75,762 of those forms (release of August 15, 2026).
- Match the inspection dates. The facility's inspection history lists each inspection with its outcome. An inspection that led to a letter is recorded with a warning-letter outcome rather than a plain 483.
- Open the Form 483 and compare sections. The sections on the 483 are usually the sections in the letter. If the letter cites fewer, FDA accepted the response on the rest.
- Read backwards. Check earlier inspections for the same CFR sections. A repeat citation is the most common reason a 483 becomes a letter.
- Check the investigators. The same investigators often return, and their record shows what they cite most.
Four facilities, traced from letter to 483
Fresenius USA Manufacturing, Ogden, Utah
The Ogden facility has 14 FDA inspections on record, 8 of which produced a Form 483. The inspection closing December 7, 2012 is recorded with a warning-letter outcome. Its 483 carries four device observations under 21 CFR 820.30 (design verification and validation) and 820.198 (complaint procedures), all cited by investigator Janet Pulver.
The drug side tells a longer story. 21 CFR 211.192, the investigation requirement, is cited six times across the site's 483 observations: in 2012, 2014, twice in 2020, in 2021, and on the March 2026 Form 483, which has two observations (211.100(a) and 211.192). The warning letter FDA issued on August 25, 2026 is built on those same two sections. Our piece on the Fresenius warning letters of 2026 walks through that letter in full.
Olympus Medical Systems, Hachioji, Japan
The Hachioji facility has three inspections on record, and two of them, April 2015 and September 2022, are recorded with a warning-letter outcome. Both cited 21 CFR 803.50(a)(1), the requirement to report deaths and serious injuries; the section appears three times across the site's 483s. The September 2022 483 has a single observation. One observation was enough, because it repeated the 2015 finding.
The third inspection, in November 2025, produced a 483 citing 820.100(a), 820.30(a) and 820.30(g). Its observations were cited by Janet Pulver and Rebecca E Dorsey; Pulver is the investigator who cited Ogden in 2012. Janet Pulver's record shows 209 inspections across 185 sites and 1,119 observations since December 2008, and in November 2025 she inspected three Olympus facilities in Japan in consecutive weeks.
Zhejiang Huahai Pharmaceutical, Linhai, China
Zhejiang Huahai's Linhai facility (FEI 3003999190) has 12 inspections on record and 6 Form 483s. The January 2025 inspection is recorded with a warning-letter outcome; FDA's letter to this FEI, issued June 6, 2025, cites among other violations 21 CFR 211.67(a), equipment cleaning and maintenance. Before it: 483s in July and November 2016 and two in 2019, separated by clean inspections. After it: another 483 in April 2026. A clean inspection in between does not reset the history.
Granules India, Medchal-Malkhajgiri district, India
The Granules facility (FEI 3004097901) has 8 inspections on record. Three clean inspections from 2015 to 2018 were followed by 483s in February 2020 and January 2023, and then the August to September 2024 inspection, recorded with a warning-letter outcome. Two 483s in a row, then the letter: the most common shape in the record.
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FDA warning letter database vs FDA Data Dashboard vs a facility-history database
Each source answers a different question. The warning letter database tells you what FDA said. The FDA Data Dashboard tells you how FDA classified each inspection. A facility-history database tells you what was cited at each inspection and by whom.
| FDA warning letter database | FDA Data Dashboard | Facility-history database (Atlas) | |
|---|---|---|---|
| What it holds | Full text of posted warning letters | Inspections, classifications (NAI, VAI, OAI), citations, compliance actions, recalls | Inspections, Form 483s and observations, investigators, outcome per inspection |
| Search by company or FEI | Company name and text; FEI via text | Yes | Yes |
| Filter by issuing office and subject | Yes | By product type and center | By product category |
| Inspection classification | No | Yes | Outcome per inspection (clean, 483, warning letter) |
| Form 483 observations | No | CFR section and short description of citations | Observation, CFR section and investigator for each |
| Search by investigator | No | No | Yes, 6,103 investigators |
| Closeout and response letters | Yes | No | No |
| Link letter to earlier 483s | Manual | Partial | Full inspection history on one page |
| Cost | Free | Free | Free directory |
For a supplier review, use all three: the letter database for the letter text and closeout status, the Dashboard for FDA's own classification (our explainer on NAI, VAI and OAI covers what each means), and the facility history for the sections cited before the letter.
What the warning letter database will not show you
Three things are missing from the letter table, and each one matters when you are judging risk:
- The near misses. Most inspections with a 483 never become a letter. Atlas holds 4,584 Form 483s with observation detail from 2025 alone (data to July 2026). A facility with three 483s citing the same section and no letter yet is not in the warning letter database at all.
- The investigator. Letters are signed by a center official, not the investigator who wrote the 483. The investigator's history tells you what the next inspection will look at.
- What is a 483 and what is a letter. If you are new to the documents, our primer on what an FDA Form 483 is explains how observations become findings and findings become letters.
AtlasFDA Inspection Intelligence Digest
We track every 483, EIR, and warning letter the moment it happens. Get the signals before they hit the FDA website.
Frequently asked questions
Yes. FDA posts warning letters on its website, usually within a few weeks of issue, with commercial confidential information and personal details redacted. Not every letter is posted at once, and some are posted months later. Company response letters are only posted if the company asks FDA to post them.
Written by
Bhavish Agarwal
Founder, Atlas
Bhavish Agarwal is the founder of Atlas and previously worked at Google and Microsoft. He has spent the past several years building regulatory data infrastructure for the pharmaceutical industry.
