Nikko Yakuhin Kogyo Co.,Ltd.
FDA import alert and refusal historyNagoya, JapanFEI 3007781235
Recorded by FDA as NIKKO YAKUHIN KOGYO CO.,LTD.
As of October 26, 2026, Nikko Yakuhin Kogyo Co.,Ltd. (Nagoya, Japan) is on the red list of FDA Import Alert 54-14 (Supplements from firms not meeting supplement GMP) for pure gold collagen, published by FDA on March 21, 2017, and has 3 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 54-14 · red list
- Last import refusal
- Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · SUPPL GMP
- Last warning letter
- None found
- Last inspection
- Classified OAI (Official Action Indicated)
Every FDA record for Nikko Yakuhin Kogyo Co.,Ltd.
5 records, newest first. Each line links to the FDA page it came from.
2017
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry UPS-4922670-8Source
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry E8L-1044274-2Show 2 linesHide lines
- Import alert listingListed on Import Alert 54-14red listPure Gold CollagenSource
2016
- InspectionInspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
Refusal charges, in plain English
- SUPPL GMP3 refused lines
Dietary supplement CGMP not met
The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.
Questions about Nikko Yakuhin Kogyo Co.,Ltd.
- Is Nikko Yakuhin Kogyo Co.,Ltd. on an FDA import alert?
- Yes. As of October 26, 2026, Nikko Yakuhin Kogyo Co.,Ltd. is on the red list of FDA Import Alert 54-14, “Supplements from firms not meeting supplement GMP”, for pure gold collagen; FDA published the listing on March 21, 2017.
- Has FDA refused shipments from Nikko Yakuhin Kogyo Co.,Ltd.?
- Yes. FDA refused 3 shipment lines from Nikko Yakuhin Kogyo Co.,Ltd. between July 3, 2017 and September 1, 2017. The most recent, on September 1, 2017, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as SUPPL GMP (dietary supplement cgmp not met).
- Why did FDA refuse Nikko Yakuhin Kogyo Co.,Ltd.'s shipments?
- The most frequent charge is SUPPL GMP (dietary supplement cgmp not met, 3 lines).
- When was Nikko Yakuhin Kogyo Co.,Ltd. last inspected by FDA?
- FDA's most recent inspection of Nikko Yakuhin Kogyo Co.,Ltd. with a final classification is dated August 5, 2016 and was classified OAI (Official Action Indicated).
- What is Nikko Yakuhin Kogyo Co.,Ltd.'s FEI number?
- Nikko Yakuhin Kogyo Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3007781235.
- Can shipments from Nikko Yakuhin Kogyo Co.,Ltd. still enter the U.S.?
- Shipments of pure gold collagen from Nikko Yakuhin Kogyo Co.,Ltd. can be detained without physical examination under Import Alert 54-14; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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