1Where each record is published.
FDA’s Data Dashboard brings FDA’s public compliance data into one place: inspections, compliance actions, recalls, imports and import refusals, updated weekly. Its data can also be downloaded or reached through an API, for which FDA issues credentials through its OII Unified Logon application.¹² For drug firms it covers inspections and compliance actions from 2009 to the present.³ Other records sit elsewhere.
| What you want | Where to look | What to know |
|---|---|---|
| Inspection dates and NAI, VAI or OAI classifications | Data Dashboard, Inspections | Final classifications only, one for each project area inspected, updated weekly.⁴ |
| What a 483 cited | Data Dashboard, inspection citations | Only 483s generated by FDA’s electronic inspection tools.⁴ |
| The 483 itself | Data Dashboard “Published 483s” table, and the OII FOIA Electronic Reading Room | Only 483s cleared and published in the Reading Room.⁴⁵ |
| Warning letters and close-out letters | FDA’s Warning Letters page | Searchable, and filterable by issuing office, issue date, posting date and whether a response or close-out letter is posted.⁶ |
| Import detention for CGMP failures | Import Alert 66-40 and its red list | Drugs from foreign firms that have not met drug GMPs.⁷ |
| How often each regulation is cited | Inspection Observations spreadsheets, FY 2006 to FY 2025 | Counts by area of regulation and product area, not a list of every observation.⁸ |
| EU GMP status | EudraGMDP | GMP certificates, non-compliance statements, manufacturing and import authorisations and active substance manufacturer registrations.⁹ |
2What the Data Dashboard shows, and what it leaves out.
The inspections dashboard shows final classifications of NAI, VAI or OAI for each project area within an inspection. It includes drug inspections by mutual recognition partners once FDA has classified them.⁴ It leaves out inspections conducted by states, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action and inspections of nonclinical laboratories.¹⁰ Some records for an inspection with a final classification may not be available under FOIA until it is closed under 21 CFR 20.64(d), and some information may be withheld from posting until planned compliance actions are taken.⁴
Read the citation data with care. Citations from manually prepared 483s do not appear, and a 483 changed outside FDA’s electronic tools may not match what the firm received. MDSAP audit reports have been removed from the dashboard.⁴ And the time since a site’s last surveillance inspection “should not be interpreted as a measure of facility or product quality”, because FDA prioritises drug sites for inspection by risk.⁴
3Getting a 483 that is not published.
A 483 or Establishment Inspection Report appears in the OII FOIA Electronic Reading Room only if FDA chooses to disclose it proactively or if three or more people have asked for the same record under the Freedom of Information Act, the “three or more rule” of 5 U.S.C. 552(a)(2)(D).⁵ Posted records may be partly redacted under 21 CFR Part 20 to protect information such as trade secrets, confidential commercial information and personal information. Company responses to 483s and warning letters are generally not posted, and records stay on the page for five years before archiving.⁵ FDA sets no timeframe for posting 483s.²
If a record is not there, request it through FDA’s online FOIA portal, which FDA asks all requesters to use.⁵ An empty result is not evidence of a clean record: “A record not found is not the same as a missing inspection.”⁵
4Reading warning letters, close-outs and import alerts.
When FDA identifies what it believes are significant violations, it often notifies the company with a warning letter, which identifies the concerns and requests a response within a set time.¹¹ The listing warns that later interaction between FDA and the recipient may have changed the regulatory status of the issues described.⁶ For letters issued on or after 1 September 2009, FDA may issue a close-out letter once it has verified the corrective actions, usually by a follow-up inspection. It does not issue one “based on representations that some action will or has been taken”.¹¹ Warning letters are typically posted within one or two weeks of issue.²
Under Import Alert 66-40, FDA divisions may detain without physical examination drugs from foreign establishments on the alert’s red list, when an inspection or other information shows the establishment is not operating in conformity with CGMP. Removal needs evidence that the conditions have been resolved, and when the listing is coupled with a warning letter or similar action, FDA generally inspects to confirm the corrections before removing the firm.⁷
5Using what you find in supplier qualification.
After inspecting a manufacturing site, including sites outside the EU that supply it, EU competent authorities issue a GMP certificate or a non-compliance statement and enter it in EudraGMDP, which has a public version.⁹¹²
Public records inform a supplier decision; they do not make it. ICH Q7 expects supplier approval to include an evaluation that provides adequate evidence, such as past quality history, that the manufacturer can consistently supply material meeting specifications.¹³ For devices, FDA notes that certification “may not provide adequate assurances of supplier quality without further evaluation”.¹⁴ An absent record proves little either way: the Reading Room says the absence of a facility “should not be interpreted to mean that the facility has not been subject to appropriate regulatory oversight”.⁵
6How it runs in Seal.
In Seal’s supplier quality workflow, approval is scoped by supplier, manufacturer, site, material or service, grade, product use, market, conditions and effective dates, rather than applying to the company as a whole. Requalification brings together the current scope, performance, changes, audit findings and open commitments, and a restriction or suspension takes effect by date, with its approvals.
Neil can check a receipt against the approved scope and draft the comparison for supplier quality, who decide qualification and material disposition; approval of one site does not automatically cover another site owned by the same company. Supplier scorecards count delivery and quality from receipts, inspections and nonconformances, and every number links to the records it was counted from.
References
- 1FDA Data Dashboard, FDA. https:/
/ datadashboard. fda. gov/ oii/ index. htm (read 6 November 2026) - 2Overview of Drug Manufacturing Inspections, Understanding FDA Inspections and Data webinar, FDA, 6 September 2023. https:/
/ www. fda. gov/ media/ 172786/ download (read 6 November 2026) - 3Pharmaceutical Inspections and Compliance, FDA Center for Drug Evaluation and Research, December 2024. https:/
/ www. fda. gov/ drugs/ guidance- compliance- regulatory- information/ pharmaceutical- inspections- and- compliance (read 6 November 2026) - 4FDA Data Dashboard, Inspections, FDA. https:/
/ datadashboard. fda. gov/ oii/ cd/ inspections. htm (read 6 November 2026) - 5OII FOIA Electronic Reading Room, FDA Office of Inspections and Investigations, November 2026. https:/
/ www. fda. gov/ about- fda/ office- inspections- and- investigations/ oii- foia- electronic- reading- room (read 6 November 2026) - 6Warning Letters, FDA, November 2026. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ compliance- actions- and- activities/ warning- letters (read 6 November 2026) - 7Import Alert 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs, FDA, published 27 October 2026. https:/
/ www. accessdata. fda. gov/ cms_ ia/ importalert_ 189. html (read 6 November 2026) - 8Inspection Observations, FDA, December 2025. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ inspection- references/ inspection- observations (read 6 November 2026) - 9Good manufacturing practice, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice (read 6 November 2026) - 10Inspection classifications, FDA, April 2024. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ inspection- basics/ inspection- classifications (read 6 November 2026) - 11About Warning and Close-Out Letters, FDA, March 2024. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ about- warning- and- close- out- letters (read 6 November 2026) - 12EudraGMDP database, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice/ eudragmdp- database (read 6 November 2026) - 13ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH, 10 November 2000, section 7.31. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 14Medical Devices; Quality System Regulation Amendments, final rule, 89 FR 7496, FDA, 2 February 2024. https:/
/ www. federalregister. gov/ documents/ 2024/ 02/ 02/ 2024- 01709/ medical- devices- quality- system- regulation- amendments (read 6 November 2026)
AQuestions and answers
Are all FDA Form 483s made public?
No. FDA posts a redacted 483 only when it decides to disclose it proactively or when three or more people have requested the same record under FOIA. Otherwise you can request it through FDA’s online FOIA portal. Trade secrets, confidential commercial information and personal information are removed before release.
Why is a supplier missing from FDA’s Data Dashboard?
Several kinds of inspection are left out, including state inspections, pre-approval inspections and inspections still waiting for a final enforcement action, and records can be held back while a compliance action is open. FDA warns that a facility’s absence from its public data does not mean it has not been overseen.
What does a warning letter close-out letter mean?
That FDA has evaluated the company’s corrective actions and verified that they were made, usually through a follow-up inspection. Close-out letters exist only for warning letters issued on or after 1 September 2009, and FDA does not issue one on the strength of promises.
Can I see how a company responded to its 483 or warning letter?
Usually not from FDA’s website. Company responses are generally not posted in the OII Reading Room unless they have been released through a FOIA request or proactive disclosure. You can request them through FOIA, or ask the supplier directly as part of your qualification.
How do I check an EU manufacturer’s GMP status?
Search the public version of EudraGMDP. It holds manufacturing and import authorisations, registrations of active substance manufacturers, and the GMP certificates and non-compliance statements EU and EEA authorities issue after inspecting a site.
Is a clean FDA inspection history enough to qualify a supplier?
No. It is one input. ICH Q7, for example, expects evidence such as past quality history, full analysis of at least three batches before reducing in-house testing, and periodic checks that the supplier’s certificates of analysis are reliable. FDA also says the time since a site’s last inspection is not a measure of its quality.