FDA inspections of firms in Waltham, MA
49 firms in Waltham were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 21 NAI, 26 VAI, 2 OAI. Main product types: Devices (20), Drugs (17), Biologics (9).
| Firm | Product types | Inspections | Latest inspection | 483 observations posted |
|---|---|---|---|---|
| Aimmune Therapeutics Manufacturing, LLC FEI 3021578714 | Biologics | 2 | Jul 25, 2025 · NAI | — |
| Akebia Therapeutics, Inc. FEI 3012772815 | Drugs | 1 | Aug 12, 2021 · NAI | — |
| Alcresta Therapeutics, Inc. FEI 3009596666 | Devices | 3 | Aug 16, 2023 · NAI | — |
| Alkermes, Inc. FEI 1000513229 | Drugs | 4 | May 28, 2015 · NAI | 2 |
| Apellis Pharmaceuticals, Inc. FEI 3016603289 | Drugs | 2 | Jul 14, 2023 · NAI | — |
| Beaver-Visitec International, Inc. FEI 1211998 | Devices | 5 | Feb 13, 2025 · NAI | 3 |
| Biosystems Of New England, Inc. FEI 3003929762 | Biologics | 2 | Sep 18, 2013 · NAI | — |
| Boston IVF FEI 3004514164 | Biologics | 6 | Sep 19, 2024 · NAI | — |
| Cato Research Boston FEI 3005469004 | Devices | 1 | Feb 22, 2010 · NAI | — |
| Charles Manero Catering Co., Inc. FEI 3006492291 | Food/Cosmetics | 1 | Feb 21, 2020 · VAI | 3 |
| Checkpoint Therapeutics, Inc. FEI 3016858328 | Drugs | 1 | Jun 16, 2023 · NAI | — |
| Cogent Biosciences, Inc. FEI 3026919714 | Drugs | 1 | Apr 24, 2026 · NAI | — |
| Corindus Inc FEI 3007822508 | Devices | 2 | Jul 27, 2021 · VAI | 2 |
| CorneaGen - Boston FEI 1000513310 | Biologics | 5 | Mar 5, 2020 · NAI | 3 |
| Correx, Inc. FEI 3007710369 | Devices | 1 | Mar 2, 2012 · VAI | 6 |
| Covidien LLC dba Confluent Surgical FEI 3003157248 | Devices | 1 | Nov 3, 2010 · VAI | 3 |
| Covis Pharma GmBH FEI 3008152278 | Drugs | 8 | Sep 19, 2024 · NAI | 9 |
| Deciphera Pharmaceuticals, LLC FEI 3014755495 | Drugs | 3 | Jun 3, 2026 · NAI | — |
| Dentsply IH, Inc. FEI 1000120733 | Biologics; Devices | 3 | Jan 11, 2017 · NAI | 1 |
| Entasis Therapeutics Holdings, Inc. FEI 3011575684 | Drugs | 1 | Jul 24, 2025 · NAI | — |
| Eurofins DPT, LLC FEI 3011026313 | Biologics | 4 | Jan 30, 2025 · NAI | 1 |
| Fresenius Medical Care Renal Therapies Group, LLC FEI 3001451489 | Devices; Drugs | 8 | Oct 16, 2024 · OAI | 35 |
| Hemedex, Inc. FEI 3003730855 | Devices | 5 | Aug 19, 2026 · VAI | 5 |
| ImmunoGen, Inc. FEI 1000513178 | Drugs | 1 | Jul 28, 2022 · NAI | — |
| Industrial & Biomedical Sensors Corporation FEI 1218924 | Devices | 2 | Dec 15, 2010 · VAI | 10 |
| Inverness Medical, LLC FEI 1000137569 | Devices | 2 | Feb 26, 2013 · NAI | — |
| Italian Ready Meals, LLC FEI 3015168099 | Food/Cosmetics | 1 | Mar 17, 2023 · NAI | — |
| Jali Medical, Incorporated FEI 1000137701 | Devices | 2 | Jul 24, 2018 · VAI | 3 |
| La Jolla Pharmaceutical Company FEI 3012862419 | Drugs | 1 | Dec 1, 2022 · NAI | — |
| Lizzy's Ice Cream Llc FEI 3003744124 | Food/Cosmetics | 1 | Aug 14, 2009 · VAI | 2 |
| Lumicell, Inc. FEI 3017718237 | Devices | 1 | Aug 18, 2023 · VAI | 1 |
| Medi-rents, Inc. FEI 1000121105 | Drugs | 1 | Feb 26, 2010 · NAI | — |
| Mr. C's Specialty Food, LLC. FEI 3006548047 | Food/Cosmetics | 3 | Dec 18, 2017 · NAI | 9 |
| NanoEnTek America Inc FEI 3007113174 | Devices | 1 | Mar 1, 2024 · VAI | 5 |
| New England Donor Services, Inc. FEI 3002920128 | Biologics | 5 | Jan 28, 2025 · NAI | 3 |
| Nova Biomedical Corporation FEI 1219029 | Devices | 3 | Apr 4, 2017 · VAI | 3 |
| Olympus Scientific Solutions Americas Corp. FEI 3006241029 | Devices | 2 | Aug 15, 2013 · NAI | 2 |
| PerkinElmer Health Sciences, Inc. FEI 3006159931 | Devices | 3 | Aug 1, 2019 · VAI | — |
| Repligen Corporation FEI 3009352682 | Drugs | 1 | Feb 29, 2012 · NAI | — |
| Respiratory Motion Inc FEI 3010258143 | Devices | 1 | Nov 26, 2013 · VAI | 2 |
| Rhytec Inc. FEI 3004948955 | Devices | 1 | Dec 15, 2008 · NAI | — |
| SLADE GORTON & CO., INC. FEI 1213569 | Food/Cosmetics | 6 | Nov 17, 2025 · NAI | 10 |
| Sobi, Inc. FEI 3012511995 | Drugs | 1 | Nov 22, 2022 · NAI | — |
| Strawberry Hill Grand Delights, LLC. FEI 3007748609 | Food/Cosmetics | 2 | Nov 20, 2019 · NAI | — |
| Surgi-Care, Inc. FEI 3003435341 | Biologics | 5 | Feb 10, 2020 · NAI | 7 |
| Tesaro a GSK Company FEI 3009154441 | Drugs | 4 | May 12, 2020 · NAI | — |
| Thea Pharma, Inc. FEI 3022351866 | Biologics; Drugs | 2 | Oct 18, 2024 · NAI | — |
| Village Fertility Pharmacy, Inc. FEI 3008335877 | Drugs | 1 | Mar 13, 2013 · OAI | — |
| ZSFAB Inc FEI 3022943642 | Devices | 1 | May 16, 2025 · VAI | — |
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.