FDA establishment 3009389940, Northborough, Massachusetts, United States. Part of Genzyme's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Aug 14, 2025 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Feb 14, 2025 | Biologics · Blood and Blood Products | 3 cited references
| Voluntary Action Indicated (VAI) |
| Feb 28, 2020 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jul 19, 2018 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Aug 18, 2016 | Drugs · Drug Quality Assurance | 3 cited references
| Voluntary Action Indicated (VAI) |
| Sep 18, 2014 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Apr 9, 2013 | Devices · Project Evaluation: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Feb 17, 2012 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Recalled product | Class | Classified |
|---|---|---|
| Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva…Drug · D-0075-2018 | Class III | Oct 12, 2017 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Northborough, Massachusetts, United States. Part of