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Ryukakusan Co. Ltd.

FDA import alert and refusal historyKatori-Gun, JapanFEI 3009872012

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Example subjectRyukakusan Co. Ltd added to Import Alert 16-129 (red list)

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As of October 26, 2026, Ryukakusan Co. Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines between November 15, 2016 and September 22, 2017, most often for unapproved new drug (UNAPPROVED).

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

Current status

Import alerts
Not listed
Last import refusal
Flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate) · DIRECTIONS
Last warning letter
None found
Last inspection
None on record

Every FDA record for Ryukakusan Co. Ltd.

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

2017

  1. Import refusal
    Refused, Flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate)DIRECTIONSUNSAFE ADDPOISONOUSUNAPPROVEDEntry WT8-0314179-3
    Source

2016

  1. Import refusal
    Refused, 4 lines in one entry: Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry BXM-0015328-7Show 4 lines
    Source

Refusal charges, in plain English

  • UNAPPROVED5 refused lines

    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.

  • DIRECTIONS1 refused line

    DIRECTIONS

  • POISONOUS1 refused line

    Poisonous or deleterious substance

    The product appeared to bear or contain a poisonous or deleterious substance which may render it injurious to health.

  • UNSAFE ADD1 refused line

    Food additive unsafe under section 409

    The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

Questions about Ryukakusan Co. Ltd.

Is Ryukakusan Co. Ltd. on an FDA import alert?
No listing for Ryukakusan 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 Ryukakusan Co. Ltd.?
Yes. FDA refused 5 shipment lines from Ryukakusan Co. Ltd. between November 15, 2016 and September 22, 2017. The most recent, on September 22, 2017, was flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate), charged as DIRECTIONS (directions).
Why did FDA refuse Ryukakusan Co. Ltd.'s shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and DIRECTIONS (directions, 1 line).
What is Ryukakusan Co. Ltd.'s FEI number?
Ryukakusan Co. Ltd.'s FDA Establishment Identifier (FEI) is 3009872012.

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Example subjectRyukakusan 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.