Meriter Health Enterprises FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Meriter Health Enterprises has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Meriter Health Enterprises" is on file. FDA has published 1 Form 483 for Meriter Health Enterprises.

What these totals cover: FDA records filed under the name "Meriter Health Enterprises".

Latest inspection
May 7, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Meriter Health Enterprises's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Meriter Health Enterprises: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
202000000
201900000
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Meriter Health Enterprises as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Meriter Health Enterprises yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Meriter Health Enterprises Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
May 7, 20254833009166489

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

5 inspections from Nov 12, 2013 to May 7, 2025.

DateSiteProductClassificationFEI
May 7, 2025Madison, WIBiologicsVoluntary Action Indicated (VAI)3009166489
Feb 10, 2022Madison, WIBiologicsNo Action Indicated (NAI)3009166489
Oct 31, 2017Madison, WIBiologicsNo Action Indicated (NAI)3009166489
Dec 18, 2015Madison, WIBiologicsNo Action Indicated (NAI)3009166489
Nov 12, 2013Madison, WIBiologicsNo Action Indicated (NAI)3009166489
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3009166489Madison, WI5May 7, 2025

Meriter Health Enterprises and the FDA: common questions

Has Meriter Health Enterprises received an FDA warning letter?

No FDA warning letter addressed to the name "Meriter Health Enterprises" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Meriter Health Enterprises received an FDA Form 483?

FDA has published 1 Form 483 for Meriter Health Enterprises in its reading room, the most recent dated May 7, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Meriter Health Enterprises?

The most recent FDA inspection on file ended May 7, 2025 at Madison, WI and was classified VAI. FDA has 5 inspections of Meriter Health Enterprises on file.

Need more than this page shows? Ask about Meriter Health Enterprises in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.