FDA inspections of firms in Lexington, MA
22 firms in Lexington were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 11 NAI, 10 VAI, 1 OAI. Main product types: Drugs (11), Devices (8), Biologics (4).
| Firm | Product types | Inspections | Latest inspection | 483 observations posted |
|---|---|---|---|---|
| Agenus Inc. FEI 3010144196 | Drugs | 1 | Jul 28, 2021 · NAI | — |
| Aldeyra Therapeutics, Inc. FEI 3013989915 | Drugs | 1 | Apr 28, 2023 · VAI | 1 |
| Boston IVF, Inc. LLC FEI 3003928198 | Biologics | 5 | Jan 9, 2020 · NAI | — |
| CSA Medical, Inc. FEI 3010140265 | Devices | 1 | Oct 24, 2013 · NAI | — |
| Epix Pharmaceuticals FEI 3006018429 | Drugs | 1 | Jul 9, 2009 · NAI | — |
| Fractyl Laboratories, Inc. FEI 3012744132 | Devices | 1 | Aug 6, 2019 · NAI | — |
| FUJIFILM Healthcare Americas Corporation FEI 1000513161 | Devices | 6 | Jun 21, 2019 · VAI | 7 |
| FUJIFILM HEALTHCARE AMERICAS CORPORATION FEI 3008491142 | Devices | 1 | Nov 17, 2017 · NAI | — |
| GENEZEN MA, INC. FEI 3032138608 | Biologics | 1 | Aug 27, 2025 · NAI | — |
| Hightech American Industrial Laboratories, Inc. FEI 3003046678 | Devices | 4 | Jan 25, 2022 · VAI | 9 |
| InaVein LLC FEI 3006891502 | Devices | 2 | Oct 1, 2010 · VAI | 5 |
| Kaleido Biosciences, Inc. FEI 3012884265 | Drugs | 1 | Mar 3, 2021 · OAI | 1 |
| Merck Sharp & Dohme Corp. FEI 1000513172 | Drugs | 7 | Sep 4, 2014 · NAI | 9 |
| Partner Therapeutics, Inc. FEI 3017531261 | Drugs | 2 | Dec 4, 2024 · NAI | 2 |
| Shire Human Genetic Therapies, Inc. FEI 3009340644 | Drugs | 20 | Dec 18, 2025 · VAI | 5 |
| Shire, PLC FEI 3013975505 | Drugs | 1 | Apr 9, 2018 · NAI | — |
| Sun Pharmaceutical Industries Inc FEI 3028772083 | Drugs | 1 | Feb 15, 2024 · NAI | — |
| Synageva Biopharma FEI 3010388967 | Drugs | 1 | Jun 3, 2015 · VAI | 1 |
| T2 Biosystems, Inc. FEI 3010097867 | Devices | 2 | Sep 24, 2021 · VAI | 5 |
| Takeda Development Center Americas FEI 3015492352 | Biologics | 1 | Jun 5, 2023 · NAI | — |
| Takeda Pharmaceuticals U.S.A. FEI 3016938816 | Biologics; Drugs | 2 | Sep 1, 2021 · NAI | — |
| Tepha Incorporated FEI 3005670760 | Devices | 4 | May 13, 2022 · VAI | 2 |
Alphabetical order — this site ranks no firm. Inspections from fiscal year 2009 to 2026; the classification is the FDA's (NAI no action indicated, VAI voluntary action indicated, OAI official action indicated). Select a firm for every inspection, the posted Form 483 observations and any compliance action. How to read this.