OU-DEAN FOODS FACTORY CO., LTD
⚠️ Moderate Risk
FEI: 3010137399 • Changhua Hsien, Changhua • TAIWAN
FEI Number
3010137399
Location
Changhua Hsien, Changhua
Country
TAIWANAddress
Pei-Tou Industrial Park, NO. 20 Hsin Kong Rd., Changhua Hsien, Changhua, Taiwan
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
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.
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).
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2011 | 29CGT99NONALCOHOLIC BEVERAGES, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/27/2010 | 29AEE02SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED | Los Angeles District Office (LOS-DO) | |
| 5/27/2010 | 29AEE02SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED | Los Angeles District Office (LOS-DO) | |
| 5/27/2010 | 29AEE08SOFT DRINK, VINE FRUIT FLAVORED, NONCARBONATED | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 8/31/2006 | 21VET07PINEAPPLE, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | Seattle District Office (SEA-DO) | |
| 11/29/2005 | 29AEE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 11/29/2005 | 29AET99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 11/29/2005 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is OU-DEAN FOODS FACTORY CO., LTD's FDA import refusal history?
OU-DEAN FOODS FACTORY CO., LTD (FEI: 3010137399) has 8 FDA import refusal record(s) in our database, spanning from 11/29/2005 to 11/2/2011.
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. OU-DEAN FOODS FACTORY CO., LTD's FEI number is 3010137399.
What types of violations has OU-DEAN FOODS FACTORY CO., LTD received?
OU-DEAN FOODS FACTORY CO., LTD has been cited for 7 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 OU-DEAN FOODS FACTORY CO., LTD come from?
All FDA import refusal data for OU-DEAN FOODS FACTORY 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.