New England Life Care, Inc. FDA Record

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

New England Life Care, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to New England Life Care, Inc., the most recent on May 16, 2023. FDA has published 2 Form 483s for New England Life Care, Inc..

What these totals cover: FDA records filed under the name "New England Life Care, Inc." and its spelling variant "New England Life Care".

Latest inspection
Apr 28, 2022 · OAI

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
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

New England Life Care, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

New England Life Care, Inc.: FDA inspections per year 2017: 0 inspections020172018: 2 inspections220182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300100
202211000
202100000
202000000
201900000
201820000
201700000

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 New England Life Care, Inc. 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 New England Life Care, Inc. 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

New England Life Care, Inc. FDA Warning Letters

1 warning letter on May 16, 2023.

IssuedSubjectIssuing officeClose-out letter
May 16, 2023

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

New England Life Care, Inc. Form 483s

2 Form 483s published by FDA.

DateDocumentFEI
Apr 9, 20184831000159373
Mar 6, 20184833014174643

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

3 inspections from Feb 8, 2018 to Apr 28, 2022.

DateSiteProductClassificationFEI
Apr 28, 2022Woburn, MADrugsOfficial Action Indicated (OAI)3014174643
Mar 2, 2018Portland, MEDrugsVoluntary Action Indicated (VAI)1000159373
Feb 8, 2018Woburn, MADrugsVoluntary Action Indicated (VAI)3014174643
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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under New England Life Care, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 16, 2023.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014174643Woburn, MA2Apr 28, 2022
FEI 1000159373Portland, ME1Mar 2, 2018

New England Life Care, Inc. and the FDA: common questions

Has New England Life Care, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to New England Life Care, Inc.. The most recent is dated May 16, 2023.

Has New England Life Care, Inc. received an FDA Form 483?

FDA has published 2 Form 483s for New England Life Care, Inc. in its reading room, the most recent dated Apr 9, 2018. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect New England Life Care, Inc.?

The most recent FDA inspection on file ended Apr 28, 2022 at Woburn, MA and was classified OAI. FDA has 3 inspections of New England Life Care, Inc. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about New England Life Care, Inc. 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.