SupplierRadar
Sign inStart free

Ezai CO., LTD

FDA import alert and refusal historyBunkyo, JapanFEI 3015216239

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Ezai CO., LTD.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectEzai CO., LT added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

As of October 26, 2026, Ezai CO., LTD is not on any FDA import alert in SupplierRadar's records; FDA refused 7 of its shipment lines between June 27, 2019 and May 6, 2022, most often for required label information not in english (NO ENGLISH).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Vitamin b12 (cyanocobalamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Ezai CO., LTD

7 records, newest first. Each line links to the FDA page it came from.

2022

  1. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-1039684-2
    Source

2019

  1. Import refusal
    Refused, 6 lines in one entry: Soft drinks and waters not mentioned elsewhere, n.e.c.; Noncarbonated soft drink, n.e.c.NO ENGLISHEntry 349-1006847-6Show 6 lines
    • Refused, Soft drinks and waters not mentioned elsewhere, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    • Refused, Soft drinks and waters not mentioned elsewhere, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    • Refused, Noncarbonated soft drink, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    • Refused, Noncarbonated soft drink, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    • Refused, Soft drinks and waters not mentioned elsewhere, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    • Refused, Soft drinks and waters not mentioned elsewhere, n.e.c.NO ENGLISHEntry 349-1006847-6Source
    Source

Refusal charges, in plain English

  • NO ENGLISH6 refused lines

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • UNAPPROVED1 refused line

    Unapproved new drug

    The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about Ezai CO., LTD

Is Ezai CO., LTD on an FDA import alert?
No listing for Ezai CO., LTD appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Japan page.
Has FDA refused shipments from Ezai CO., LTD?
Yes. FDA refused 7 shipment lines from Ezai CO., LTD between June 27, 2019 and May 6, 2022. The most recent, on May 6, 2022, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Ezai CO., LTD's shipments?
The most frequent charges are NO ENGLISH (required label information not in english, 6 lines) and UNAPPROVED (unapproved new drug, 1 line).
What is Ezai CO., LTD's FEI number?
Ezai CO., LTD's FDA Establishment Identifier (FEI) is 3015216239.

Buying from Ezai CO., LTD?

Watch it and get the FDA record the day it changes. Free for one supplier.

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Ezai CO., LTD.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectEzai CO., LT added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.