FDA import alert status
Wenzhou Bokang Instrument Co., Ltd.
China · appears on 2 FDA import alerts
2
Red-list alerts
0
Green-list alerts
China
Country
11/14/2017
Last entry seen
What this means
As published on the official FDA import alert list, this firm appears on 2 red lists. A red-list firm is subject to Detention Without Physical Examination (DWPE): FDA can detain its shipments at the border automatically, without sampling. The burden shifts to the importer to prove the goods are not violative.
Import alert status changes over time. Import Alert Radar re-checks the official FDA source every day; the entries below reflect the latest refresh (2026-07-21 UTC).
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Red-list entries
- Import Alert 89-08RED · 04/17/2019
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
- Import Alert 89-17RED · 11/14/2017
Detention Without Physical Examination of Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess
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