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FDA establishment 3026586698, Stoughton, Massachusetts, United States. Part of Trax Surgical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Sep 23, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 803.17(b)(1). Info evaluated to determine if event was reportable The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.
ISO 13485:2016 Clause 7.3.1. Design and development procedures not documented Design and development procedures were not adequately documented.
ISO 13485:2016 Clause 8.2.2. Lack of documented justification for not investigating complaint(s) Justification for not investigating a complaint(s) was not adequately documented.
ISO 13485:2016 Clause 8.5.3. Preventive action procedures not documented Preventive action procedures describing the requirements for reviewing the effectiveness of the preventive action taken have not been adequately documented.
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
Stoughton, Massachusetts, United States. Part of