Takamizawa K.K.
⚠️ High Risk
FEI: 3004285095 • Nakano, Nagano • JAPAN
FEI Number
3004285095
Location
Nakano, Nagano
Country
JAPANAddress
708, Oazaangenji, Nakano, Nagano, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
RADIONUC
Article appears to contain the radionuclide, Cesium-137, a poisonous and deleterious substance which may render it injurious to health.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2015 | 25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 9/1/2015 | 25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 9/1/2015 | 25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 6/5/2015 | 25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 6/5/2015 | 25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 4/10/2015 | 25SCT04MUSHROOM, SHIITAKE, FUNGI PRODUCTS, N.E.C. | 2420RADIONUC | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 25SCE01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 25SCE01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/7/2012 | 25PGI04MUSHROOM, SHIITAKE , WHOLE (BUTTON) (FUNGI) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Takamizawa K.K.'s FDA import refusal history?
Takamizawa K.K. (FEI: 3004285095) has 9 FDA import refusal record(s) in our database, spanning from 5/7/2012 to 9/1/2015.
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. Takamizawa K.K.'s FEI number is 3004285095.
What types of violations has Takamizawa K.K. received?
Takamizawa K.K. 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 Takamizawa K.K. come from?
All FDA import refusal data for Takamizawa K.K. 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.