FDA inspections of firms in Cambridge, MA
77 firms in Cambridge were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 35 NAI, 42 VAI, 0 OAI. Main product types: Drugs (28), Devices (21), Biologics (17).
| Firm | Product types | Inspections | Latest inspection | 483 observations posted |
|---|---|---|---|---|
| 2seventy Bio, Inc. FEI 3020975594 | Biologics | 1 | May 6, 2022 · NAI | — |
| Advamedica, Inc. FEI 3017391151 | Devices | 1 | Dec 5, 2024 · VAI | 1 |
| Advent Medical Products, Inc. FEI 3005110371 | Devices | 2 | May 17, 2012 · NAI | — |
| Agios Pharmaceuticals, INC. FEI 3012469070 | Drugs | 2 | Sep 16, 2021 · NAI | — |
| Albireo Pharma, Inc. FEI 3014733942 | Drugs | 2 | Dec 7, 2023 · NAI | — |
| Alnara Pharmaceuticals, Inc. FEI 3008565156 | Drugs | 1 | Oct 29, 2010 · NAI | — |
| Alnylam Pharmaceuticals Inc. FEI 3013754451 | Drugs | 2 | Feb 25, 2025 · VAI | 3 |
| Alnylam Pharmaceuticals, Inc. FEI 3004080452 | Drugs | 3 | Sep 9, 2022 · NAI | — |
| AMAG Pharmaceuticals, Inc. FEI 1220373 | Drugs | 2 | May 24, 2012 · VAI | — |
| Amsel Medical Corporation FEI 3008989837 | Devices | 1 | Jun 20, 2019 · VAI | 2 |
| AO Biome Therapeutics, Inc. FEI 3011931805 | Biologics | 1 | Jun 8, 2022 · NAI | — |
| Ariad Pharmaceuticals FEI 1000513233 | Drugs | 4 | May 31, 2017 · VAI | — |
| Biogen, Inc. FEI 1220951 | Biologics; Drugs | 13 | Nov 4, 2022 · NAI | 7 |
| Blueprint Medicines Corporation FEI 3011881091 | Drugs | 3 | Nov 18, 2022 · NAI | — |
| BlueRock Therapeutics LP FEI 3014668323 | Biologics | 1 | Aug 30, 2022 · NAI | — |
| Brammer Bio MA, LLC FEI 3013417996 | Biologics | 2 | Aug 30, 2023 · VAI | — |
| California Cryobank LLC FEI 3003367577 | Biologics | 5 | Aug 15, 2025 · NAI | — |
| Cambridge Brands, Inc. FEI 1210109 | Food/Cosmetics | 4 | Feb 21, 2025 · NAI | 6 |
| Cardea Technology, Inc FEI 3007867472 | Devices | 2 | Apr 29, 2011 · VAI | 5 |
| Cellay, Inc FEI 3007738260 | Devices | 2 | Feb 10, 2016 · VAI | 5 |
| Central Bakery, Inc. FEI 1280723 | Food/Cosmetics | 5 | May 22, 2026 · VAI | 18 |
| Clover Fast Food, Inc. FEI 3010325834 | Food/Cosmetics | 1 | Jan 23, 2025 · NAI | — |
| Cromsource, Inc. FEI 3011295241 | Devices | 1 | Jul 16, 2015 · VAI | 2 |
| Curio Spice Co. FEI 3013064789 | Food/Cosmetics | 2 | Feb 28, 2020 · NAI | — |
| Empatica, Inc. FEI 3014977578 | Devices | 1 | Jan 31, 2024 · NAI | — |
| Epizyme, Inc. FEI 3009993613 | Drugs | 2 | Sep 22, 2022 · NAI | — |
| Formaggio Huron Inc. FEI 3003218353 | Food/Cosmetics | 4 | Feb 5, 2025 · NAI | 4 |
| Foundation Medicine, Inc. FEI 3010679023 | Devices | 5 | Jul 14, 2022 · NAI | 6 |
| Genocea Biosciences, Inc. FEI 3009910574 | Biologics | 1 | May 4, 2018 · NAI | — |
| Genzyme Corporation FEI 1221955 | Devices; Drugs | 9 | Aug 10, 2016 · NAI | 9 |
| Genzyme Sanofi FEI 3023205423 | Drugs | 1 | Jun 11, 2025 · NAI | — |
| Global Organics Ltd. FEI 3011778450 | Food/Cosmetics | 2 | Jul 17, 2024 · NAI | — |
| Gloucester Pharmaceuticals, Inc. FEI 3007542523 | Drugs | 1 | Jun 19, 2009 · NAI | — |
| Harvard University Area IRB FEI 3017474249 | Biologics; Devices | 1 | Nov 19, 2021 · NAI | — |
| Hummingbird IRB FEI 3010258002 | Biologics | 1 | Sep 10, 2013 · NAI | — |
| Iggy's Bread Ltd. FEI 3003742055 | Food/Cosmetics | 5 | Feb 14, 2024 · NAI | 13 |
| Invivo Therapeutics FEI 3009739497 | Devices | 1 | Dec 11, 2017 · VAI | 2 |
| Ipsen Bioscience, Inc. FEI 3008532848 | Drugs | 2 | May 20, 2025 · NAI | — |
| Ipsen Bioscience, Inc. FEI 3018842619 | Drugs | 1 | Oct 19, 2023 · NAI | — |
| Kadmon Corporation, LLC FEI 3017473155 | Drugs | 1 | Dec 8, 2020 · VAI | 1 |
| Kendall Confectionery Co., Inc. FEI 1210863 | Food/Cosmetics | 2 | Oct 19, 2016 · VAI | 1 |
| Luminopia Inc FEI 3023855046 | Devices | 1 | May 2, 2025 · VAI | 1 |
| Millennium Pharmaceuticals Inc. FEI 1000513221 | Drugs | 7 | Apr 13, 2016 · NAI | 12 |
| MIT FEI 1282959 | Devices | 1 | Sep 18, 2012 · VAI | 3 |
| Moderna US Inc. FEI 3034723791 | Biologics | 1 | Mar 11, 2025 · NAI | — |
| Momenta Pharmaceuticals, Inc. FEI 3005948218 | Drugs | 4 | May 15, 2017 · VAI | 2 |
| Mount Auburn Hospital Blood Bank FEI 1270505 | Biologics | 5 | Sep 29, 2017 · VAI | 5 |
| Mt. Auburn Hospital FEI 1283555 | Drugs | 1 | Feb 5, 2013 · NAI | — |
| Neurodyne Medical Corporation FEI 1000120636 | Devices | 2 | Dec 2, 2011 · VAI | 7 |
| Nuclea Diagnostic Laboratories, LLC. FEI 1000513165 | Devices | 2 | Dec 6, 2013 · VAI | 4 |
| Nuvalent, Inc. FEI 3017297026 | Drugs | 1 | Jan 14, 2026 · NAI | — |
| Olea Medical Solutions, Inc. FEI 3007874106 | Devices | 1 | May 2, 2016 · NAI | — |
| Omega Therapeutics, Inc. FEI 3033814262 | Biologics | 1 | Jan 17, 2025 · NAI | — |
| OPK Biotech, LLC FEI 1222147 | Veterinary | 2 | Apr 30, 2013 · VAI | 1 |
| Pathfinder Cell Therapy, Inc. FEI 1000208867 | Devices | 2 | Dec 4, 2013 · NAI | — |
| Philips North America FEI 3006648320 | Devices | 4 | Dec 13, 2023 · VAI | 10 |
| Philips Ultrasound, Inc. FEI 3017894900 | Devices | 1 | Aug 8, 2024 · VAI | — |
| Quantum Designs, LLC FEI 3009001560 | Food/Cosmetics | 1 | May 8, 2013 · NAI | — |
| Sage Therapeutics, Inc. FEI 3009322768 | Drugs | 2 | Sep 21, 2022 · NAI | — |
| Sarepta Therapeutics, Inc. FEI 3011431238 | Drugs | 3 | Dec 6, 2021 · NAI | 1 |
| Sartorius Stedim North America, Inc. FEI 3013367666 | Drugs | 1 | Jun 23, 2023 · VAI | 2 |
| Scholar Rock, Inc. FEI 3024553539 | Drugs | 1 | May 30, 2025 · NAI | — |
| Seres Therapeutics Inc FEI 3012828816 | Biologics | 2 | Jul 29, 2025 · NAI | — |
| Sesen Bio, Inc. FEI 3017545269 | Drugs | 1 | Jun 3, 2021 · NAI | — |
| Shire Human Genetic Therapies Inc FEI 3005955297 | Drugs | 8 | Sep 12, 2025 · VAI | — |
| Solid Biosciences, Inc. FEI 3015188407 | Biologics | 1 | Dec 10, 2019 · NAI | — |
| Somerville Live Poultry Co. Inc. FEI 2000030749 | Food/Cosmetics | 1 | Jun 27, 2013 · VAI | 1 |
| Sweet Spot, LLC dba Lyndell's Bakery FEI 3003440636 | Food/Cosmetics | 1 | May 18, 2011 · VAI | 3 |
| SYNLOGIC FEI 3014249614 | Biologics | 1 | Jan 23, 2019 · NAI | — |
| Takeda Pharmaceuticals, Inc. FEI 3016418550 | Drugs | 3 | Apr 10, 2026 · NAI | — |
| Takeda Pharmaceuticals, LTD FEI 3010779669 | Drugs | 1 | May 22, 2019 · NAI | — |
| The Superior Nut Company, Inc. FEI 1210487 | Food/Cosmetics | 7 | Dec 13, 2024 · VAI | 21 |
| The Zinneken'S Group Llc FEI 3010643860 | Food/Cosmetics | 2 | Aug 1, 2022 · NAI | — |
| Thomas E. Van Dyke, DDS, PhD FEI 3003059205 | Devices | 1 | Mar 31, 2016 · VAI | 2 |
| Tropic Fair Trade LLC FEI 3007482478 | Food/Cosmetics | 2 | May 19, 2022 · NAI | 2 |
| Vericel Corporation FEI 3002836339 | Biologics; Devices | 6 | Sep 25, 2024 · VAI | 16 |
| Viacord, LLC FEI 3000204460 | Biologics | 1 | Jul 28, 2009 · NAI | — |
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.