New England Life Care, Inc. FDA Record
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..
- Latest inspection
- Apr 28, 2022 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 0 |
| 2022 | 1 | 1 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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.
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.
New England Life Care, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 16, 2023 |
New England Life Care, Inc. Form 483s
| Date | Document | FEI |
|---|---|---|
| Apr 9, 2018 | 483 | 1000159373 |
| Mar 6, 2018 | 483 | 3014174643 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 28, 2022 | Woburn, MA | Drugs | Official Action Indicated (OAI) | 3014174643 |
| Mar 2, 2018 | Portland, ME | Drugs | Voluntary Action Indicated (VAI) | 1000159373 |
| Feb 8, 2018 | Woburn, MA | Drugs | Voluntary 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.
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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014174643 | Woburn, MA | 2 | Apr 28, 2022 |
| FEI 1000159373 | Portland, ME | 1 | Mar 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.