Nichiyaku, Co., Ltd.
FDA import alert and refusal historyFujinomiya, JapanFEI 3011449875
As of October 26, 2026, Nichiyaku, Co., Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines on July 23, 2025, 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
- Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- Classified NAI (No Action Indicated)
Every FDA record for Nichiyaku, Co., Ltd.
6 records, newest first. Each line links to the FDA page it came from.
2025
- Import refusalSource
Refused, 5 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Show 5 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7848666-1Source
2024
- InspectionInspection classified NAI (No Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
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.
Questions about Nichiyaku, Co., Ltd.
- Is Nichiyaku, Co., Ltd. on an FDA import alert?
- No listing for Nichiyaku, 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 Nichiyaku, Co., Ltd.?
- Yes. FDA refused 5 shipment lines from Nichiyaku, Co., Ltd. on July 23, 2025. The most recent, on July 23, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Nichiyaku, Co., Ltd.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 5 lines).
- When was Nichiyaku, Co., Ltd. last inspected by FDA?
- FDA's most recent inspection of Nichiyaku, Co., Ltd. with a final classification is dated June 5, 2024 and was classified NAI (No Action Indicated).
- What is Nichiyaku, Co., Ltd.'s FEI number?
- Nichiyaku, Co., Ltd.'s FDA Establishment Identifier (FEI) is 3011449875.
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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.