Lyophilization Services Of New England, Inc. FDA Record
- Latest inspection VAI · Jun 10, 2026
- No warning letters matched by name
Lyophilization Services Of New England, Inc. has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lyophilization Services Of New England, Inc." is on file.
- Latest inspection
- Jun 10, 2026 · VAI
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 | 12 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Lyophilization Services Of New England, Inc.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 10, 2026 | Bedford, NH | Drugs | Voluntary Action Indicated (VAI) | 3008546445 |
| Jul 8, 2025 | Manchester, NH | Devices | No Action Indicated (NAI) | 3002516348 |
| May 24, 2024 | Bedford, NH | Drugs | Voluntary Action Indicated (VAI) | 3008546445 |
| Dec 7, 2018 | Bedford, NH | Drugs | Voluntary Action Indicated (VAI) | 3008546445 |
| Feb 15, 2017 | Bedford, NH | Drugs | No Action Indicated (NAI) | 3008546445 |
| Feb 15, 2017 | Bedford, NH | Drugs | No Action Indicated (NAI) | 3008546445 |
| Jul 12, 2016 | Manchester, NH | Devices | No Action Indicated (NAI) | 3002516348 |
| Apr 24, 2015 | Bedford, NH | Drugs | Voluntary Action Indicated (VAI) | 3008546445 |
| Oct 30, 2014 | Bedford, NH | Drugs | No Action Indicated (NAI) | 3008546445 |
| Nov 13, 2013 | Manchester, NH | Devices | No Action Indicated (NAI) | 3002516348 |
| Jan 14, 2011 | Manchester, NH | Devices | No Action Indicated (NAI) | 3002516348 |
| Sep 4, 2009 | Bedford, NH | Drugs | Voluntary Action Indicated (VAI) | 3008546445 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008546445 | Bedford, NH | 8 | Jun 10, 2026 |
| FEI 3002516348 | Manchester, NH | 4 | Jul 8, 2025 |
Lyophilization Services Of New England, Inc. and the FDA: common questions
Has Lyophilization Services Of New England, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Lyophilization Services Of New England, Inc." 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 Lyophilization Services Of New England, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Lyophilization Services Of New England, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Lyophilization Services Of New England, Inc.?
The most recent FDA inspection on file ended Jun 10, 2026 at Bedford, NH and was classified VAI. FDA has 12 inspections of Lyophilization Services Of New England, Inc. on file.
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