FDA establishment 3003395329, Woburn, Massachusetts, United States. Part of Azurity Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
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 |
|---|---|---|---|
| Dec 12, 2025 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Feb 24, 2022 | Drugs · Drug Quality Assurance | 3 cited references
| Voluntary Action Indicated (VAI) |
| Jul 26, 2019 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Apr 19, 2016 | Drugs · Unapproved and Misbranded DrugsDrugs · Bioresearch Monitoring; Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jan 29, 2014 | Drugs · Unapproved and Misbranded DrugsDrugs · Bioresearch Monitoring; Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Mar 19, 2010 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices; Drugs · Drug Quality Assurance | 1 cited reference
| No Action Indicated (NAI) |
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. 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 and warning letters
Woburn, Massachusetts, United States. Part of