FDA import alert status
Sunny Optoelectronic Tech Co.Ltd
China · appears on 3 FDA import alerts
3
Red-list alerts
0
Green-list alerts
0
Yellow-list alerts
China
Country
2015-02-19
Latest indexed date
What this means
As published on the official FDA import alert list, this firm appears on 3 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 (2026-09-04 UTC).
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Red-list entries
- Import Alert 89-08RED · 02/12/2015
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 95-04RED · 07/19/2013
Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements.
- Import Alert 99-34RED · 02/19/2015
DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION AND/OR LISTING
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