FDA Import Refusal 799-2077390-2/10002/1 — NEW ERA ENTERPRISE CO.,LTD.

NEW ERA ENTERPRISE CO.,LTD. — FEI 3017808372

The FDA refused shipment 799-2077390-2/10002/1 from NEW ERA ENTERPRISE CO.,LTD. (Taiwan) on Oct 14, 2025. The refused product falls under Devices — SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE). Cited charge: 235 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Oct 14, 2025
Country
Taiwan
Product Category
Devices
Product Code
86HQY SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
Charges
235

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.