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Otsuka Pharmaceutical Co., Ltd.

FDA import alert and refusal historyChiyoda, JapanFEI 3010531572

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

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As of October 25, 2026, Otsuka Pharmaceutical Co., Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 8 of its shipment lines between February 13, 2017 and December 20, 2018, 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, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · NO ENGLISH
Last warning letter
None found
Last inspection
None on record

Every FDA record for Otsuka Pharmaceutical Co., Ltd.

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

2018

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHEntry SCS-2575866-6
    Source
  2. Import refusal
    Refused, Vitamin, n.e.c.NO ENGLISHEntry SCS-1476887-4
    Source
  3. Import refusal
    Refused, Beverage base of non-fruit origin, n.e.c.NO ENGLISHEntry SCS-1397450-7
    Source
  4. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHEntry UPS-8142402-1
    Source

2017

  1. Import refusal
    Refused, Vitamin c (ascorbic acid)NO ENGLISHEntry UPS-5856464-3
    Source
  2. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.NO ENGLISHEntry UPS-2153711-4
    Source
  3. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.NO ENGLISHEntry UPS-2104378-2
    Source
  4. Import refusal
    Refused, Beverage base not mentioned elsewhere, n.e.c.NO ENGLISHEntry UPS-2119271-2
    Source

Refusal charges, in plain English

  • NO ENGLISH8 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.

Questions about Otsuka Pharmaceutical Co., Ltd.

Is Otsuka Pharmaceutical Co., Ltd. on an FDA import alert?
No listing for Otsuka Pharmaceutical Co., Ltd. appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Japan page.
Has FDA refused shipments from Otsuka Pharmaceutical Co., Ltd.?
Yes. FDA refused 8 shipment lines from Otsuka Pharmaceutical Co., Ltd. between February 13, 2017 and December 20, 2018. The most recent, on December 20, 2018, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as NO ENGLISH (required label information not in english).
Why did FDA refuse Otsuka Pharmaceutical Co., Ltd.'s shipments?
The most frequent charge is NO ENGLISH (required label information not in english, 8 lines).
What is Otsuka Pharmaceutical Co., Ltd.'s FEI number?
Otsuka Pharmaceutical Co., Ltd.'s FDA Establishment Identifier (FEI) is 3010531572.

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Example subjectOtsuka Pharmaceutical 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.