Cambridge Isotope Laboratories, Inc. FDA Record
Cambridge Isotope Laboratories, Inc. has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cambridge Isotope Laboratories, Inc." is on file.
- Latest inspection
- May 22, 2026 · VAI
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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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 2 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 22, 2026 | Tewksbury, MA | Drugs | Voluntary Action Indicated (VAI) | 3010827078 |
| Jan 29, 2026 | Andover, MA | Drugs | No Action Indicated (NAI) | 1000513287 |
| Aug 30, 2022 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
| Dec 9, 2020 | Tewksbury, MA | Drugs | Voluntary Action Indicated (VAI) | 3010827078 |
| Nov 7, 2017 | Tewksbury, MA | Drugs | Voluntary Action Indicated (VAI) | 3010827078 |
| May 1, 2017 | Tewksbury, MA | Drugs | Voluntary Action Indicated (VAI) | 3010827078 |
| Mar 25, 2016 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
| Jan 7, 2015 | Tewksbury, MA | Drugs | Voluntary Action Indicated (VAI) | 3010827078 |
| Mar 20, 2014 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
| Aug 22, 2011 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
| Feb 11, 2010 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
| Jun 18, 2009 | Andover, MA | Drugs | Voluntary Action Indicated (VAI) | 1000513287 |
- 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 3010827078 | Tewksbury, MA | 5 | May 22, 2026 |
| FEI 1000513287 | Andover, MA | 7 | Jan 29, 2026 |
Cambridge Isotope Laboratories, Inc. and the FDA: common questions
Has Cambridge Isotope Laboratories, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Cambridge Isotope Laboratories, 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 Cambridge Isotope Laboratories, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Cambridge Isotope Laboratories, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cambridge Isotope Laboratories, Inc.?
The most recent FDA inspection on file ended May 22, 2026 at Tewksbury, MA and was classified VAI. FDA has 12 inspections of Cambridge Isotope Laboratories, Inc. on file.
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