SUNTORY HOLDINGS LIMITED
⚠️ Moderate Risk
FEI: 3010008722 • Osaka, Osaka • JAPAN
FEI Number
3010008722
Location
Osaka, Osaka
Country
JAPANAddress
Santori ( Kabu ), 2 Chome 1-40; Dojimahama; Kita, Osaka, Osaka, 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
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.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2007 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/3/2007 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/14/2003 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 62NEEDS FCE | New York District Office (NYK-DO) |
| 1/14/2003 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 62NEEDS FCE | New York District Office (NYK-DO) |
| 1/18/2002 | 31AGE99COFFEE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/18/2002 | 31KGT02TEA, GREEN | Los Angeles District Office (LOS-DO) | |
| 1/18/2002 | 31KGT02TEA, GREEN | Los Angeles District Office (LOS-DO) | |
| 1/18/2002 | 31KGT02TEA, GREEN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is SUNTORY HOLDINGS LIMITED's FDA import refusal history?
SUNTORY HOLDINGS LIMITED (FEI: 3010008722) has 18 FDA import refusal record(s) in our database, spanning from 1/18/2002 to 1/3/2007.
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. SUNTORY HOLDINGS LIMITED's FEI number is 3010008722.
What types of violations has SUNTORY HOLDINGS LIMITED received?
SUNTORY HOLDINGS LIMITED has been cited for 4 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 SUNTORY HOLDINGS LIMITED come from?
All FDA import refusal data for SUNTORY HOLDINGS LIMITED 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.