FDA establishment 3008566132, Beijing, China. Part of BMC Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Dec 1, 2014 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Recalled product | Class | Classified |
|---|---|---|
| BMC/REACTHEALTH Luna G3 APAP REF LG 3600Device · Z-2979-2026 | Class I | Jul 15, 2026 |
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