TSUKIJI OHTA CO.,LTD.
⚠️ Moderate Risk
FEI: 3013238262 • Koutou-Ku, Tokyo • JAPAN
FEI Number
3013238262
Location
Koutou-Ku, Tokyo
Country
JAPANAddress
5-2 Toyosu 6-Chome, Suite 401-A, Koutou-Ku, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
IMPTRHACCP
The food appears to have been prepared, packed or held under insanitary conditions, or may have become injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d).
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/21/2017 | 16AGC22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Division of Northeast Imports (DNEI) |
| 5/18/2017 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | Division of Northeast Imports (DNEI) | |
| 5/17/2017 | 16AGC22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Division of Northeast Imports (DNEI) |
| 5/17/2017 | 16AGC45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) | 2000IMPTRHACCP | Division of Northeast Imports (DNEI) |
| 4/28/2017 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is TSUKIJI OHTA CO.,LTD.'s FDA import refusal history?
TSUKIJI OHTA CO.,LTD. (FEI: 3013238262) has 5 FDA import refusal record(s) in our database, spanning from 4/28/2017 to 9/21/2017.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. TSUKIJI OHTA CO.,LTD.'s FEI number is 3013238262.
What types of violations has TSUKIJI OHTA CO.,LTD. received?
TSUKIJI OHTA CO.,LTD. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about TSUKIJI OHTA CO.,LTD. come from?
All FDA import refusal data for TSUKIJI OHTA CO.,LTD. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.