Siemens Medical Solutions USA, Inc

FDA establishment 2240869, Malvern, Pennsylvania, United States. Part of Siemens Medical Solutions USA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.

• Inspections: 3
• Official action indicated: 0
• Last inspection ended: Oct 26, 2022
• Warning letters: 0
• Recalls since 2016: 197
• Import refusals since 2024: 1

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