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Otsuka Seiyaku Co.,Ltd.

FDA import alert and refusal historyOsaka, JapanFEI 3004693192

Recorded by FDA as OTSUKA SEIYAKU CO.,LTD.

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Example subjectOtsuka Seiyaku Co.,Ltd added to Import Alert 16-129 (red list)

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As of October 26, 2026, Otsuka Seiyaku Co.,Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on February 13, 2017, 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
Rice, processed (packaged) n.e.c. · NO ENGLISH
Last warning letter
None found
Last inspection
None on record

Every FDA record for Otsuka Seiyaku Co.,Ltd.

1 record, newest first. Each line links to the FDA page it came from.

2017

  1. Import refusal
    Refused, Rice, processed (packaged) n.e.c.NO ENGLISHEntry UPS-2119271-2
    Source

Refusal charges, in plain English

  • NO ENGLISH1 refused line

    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.

Questions about Otsuka Seiyaku Co.,Ltd.

Is Otsuka Seiyaku Co.,Ltd. on an FDA import alert?
No listing for Otsuka Seiyaku 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 Otsuka Seiyaku Co.,Ltd.?
Yes. FDA refused 1 shipment line from Otsuka Seiyaku Co.,Ltd. on February 13, 2017. The most recent, on February 13, 2017, was rice, processed (packaged) n.e.c., charged as NO ENGLISH (required label information not in english).
Why did FDA refuse Otsuka Seiyaku Co.,Ltd.'s shipments?
The most frequent charge is NO ENGLISH (required label information not in english, 1 line).
What is Otsuka Seiyaku Co.,Ltd.'s FEI number?
Otsuka Seiyaku Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3004693192.

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Example subjectOtsuka Seiyaku Co.,Ltd added to Import Alert 16-129 (red list)

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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.