YAMAKI CO.,LTD.

⚠️ Moderate Risk

FEI: 3011502222 • Odawara, Kanagawa • JAPAN

FEI

FEI Number

3011502222

📍

Location

Odawara, Kanagawa

🇯🇵

Country

JAPAN

🏢

Address

284-17, Nishiodomo, Odawara, Kanagawa, Japan

Moderate Risk

FDA Import Risk Assessment

47.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

4/30/2003

Latest Refusal

9/9/2002

Earliest Refusal

Score Breakdown

Violation Severity

60.3×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

8314×

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.

3217×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

2185×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

624×

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).

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

Date	Product	Violations	Division
4/30/2003	04CET08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	83NO PROCESS	Los Angeles District Office (LOS-DO)
4/30/2003	04CET08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	218LIST INGRE 321LACKS N/C 83NO PROCESS	Los Angeles District Office (LOS-DO)
4/30/2003	04CET08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	218LIST INGRE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	04CGT07NOODLES, INSTANT	321LACKS N/C 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	04CGN08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	321LACKS N/C 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	04CGN08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	321LACKS N/C 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	04CGN08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	218LIST INGRE 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	04CGN08ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)	218LIST INGRE 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	02DGT03RICE, ENRICHED PROCESSED (PACKAGED)	83NO PROCESS	Los Angeles District Office (LOS-DO)
2/12/2003	02DGT03RICE, ENRICHED PROCESSED (PACKAGED)	83NO PROCESS	Los Angeles District Office (LOS-DO)
9/9/2002	04CGT07NOODLES, INSTANT	473LABELING 83NO PROCESS	Los Angeles District Office (LOS-DO)
9/9/2002	04CGT07NOODLES, INSTANT	321LACKS N/C 473LABELING 83NO PROCESS	Los Angeles District Office (LOS-DO)
9/9/2002	04CGT07NOODLES, INSTANT	321LACKS N/C 83NO PROCESS	Los Angeles District Office (LOS-DO)
9/9/2002	04CGT07NOODLES, INSTANT	218LIST INGRE 321LACKS N/C 83NO PROCESS	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is YAMAKI CO.,LTD.'s FDA import refusal history?

YAMAKI CO.,LTD. (FEI: 3011502222) has 14 FDA import refusal record(s) in our database, spanning from 9/9/2002 to 4/30/2003.

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. YAMAKI CO.,LTD.'s FEI number is 3011502222.

What types of violations has YAMAKI CO.,LTD. received?

YAMAKI CO.,LTD. has been cited for 5 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 YAMAKI CO.,LTD. come from?

All FDA import refusal data for YAMAKI 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.