FDA import alert status
Bionic Products Pty., Ltd.
Australia · appears on 1 FDA import alert
1
Red-list alerts
0
Green-list alerts
Australia
Country
12/20/2018
Last entry seen
What this means
As published on the official FDA import alert list, this firm appears on 1 red list. 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 · 12/20/2018
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
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