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FDA Import Refusal 85N-0195283-3/31/3A — Enprani Co., Ltd.

Enprani Co., Ltd. — FEI 3010822322

The FDA refused shipment 85N-0195283-3/31/3A from Enprani Co., Ltd. (South Korea) on May 9, 2025. The refused product falls under Drugs and Biologics — ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.. Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 9, 2025
Country
South Korea
Product Category
Drugs and Biologics
Product Code
66PBJ99 ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
Charges
27

Recent inspections

  • 1085302 (OAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • ATE-0317757-1/10002/2 (Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 85N-0195283-3/21/2B (Mon Jun 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 85N-0195283-3/21/2A (Mon Jun 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 85N-0195283-3/11/2B (Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 85N-0195283-3/11/2A (Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources