OSSIAN INTERNAYIONAL CO.,LTD

⚠️ Moderate Risk

FEI: 3004270773 • CHANGHUA, TW-CHA • TAIWAN

FEI

FEI Number

3004270773

📍

Location

CHANGHUA, TW-CHA

🇹🇼

Country

TAIWAN

🏢

Address

No.38,gungdung 1strd.,shengang Shiang,, Changhua County,taiwan,r.o.c, CHANGHUA, TW-CHA, Taiwan

Moderate Risk

FDA Import Risk Assessment

41.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/8/2011

Latest Refusal

8/10/2005

Earliest Refusal

Score Breakdown

Violation Severity

67.6×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

20.8×10%

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

628×

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).

838×

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.

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.

114×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3202×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3212×

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.

2382×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

3281×

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.

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

Date	Product	Violations	Division
11/8/2011	36BHT99SYRUPS AND MOLASSES, N.E.C.	238UNSAFE ADD 251POISONOUS	Los Angeles District Office (LOS-DO)
1/26/2010	21JGN99PIT FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED	11UNSAFE COL 238UNSAFE ADD	New Orleans District Office (NOL-DO)
3/10/2009	30YHT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/17/2009	21UGT99SUBTROPICAL AND TROPICAL FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/17/2009	21UGT99SUBTROPICAL AND TROPICAL FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
6/12/2008	21VGT99SUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C.	218LIST INGRE 320LACKS FIRM 321LACKS N/C 328USUAL NAME 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
6/5/2008	21UGE99SUBTROPICAL AND TROPICAL FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.	218LIST INGRE 320LACKS FIRM 321LACKS N/C 482NUTRIT LBL 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
2/6/2008	33MHE01GEL CUPS, FRUIT FLAVORED	11UNSAFE COL 218LIST INGRE 249FILTHY	San Francisco District Office (SAN-DO)
1/24/2008	23FHE05COCONUT, TOPPING	62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
1/24/2008	23FHE05COCONUT, TOPPING	11UNSAFE COL 218LIST INGRE 62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
1/24/2008	23FHE05COCONUT, TOPPING	11UNSAFE COL 218LIST INGRE 62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
8/10/2005	30YHT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	274COLOR LBLG	Los Angeles District Office (LOS-DO)
8/10/2005	30YHT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	274COLOR LBLG	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

OSSIAN INTERNAYIONAL CO.,LTD (FEI: 3004270773) has 13 FDA import refusal record(s) in our database, spanning from 8/10/2005 to 11/8/2011.

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. OSSIAN INTERNAYIONAL CO.,LTD's FEI number is 3004270773.

What types of violations has OSSIAN INTERNAYIONAL CO.,LTD received?

OSSIAN INTERNAYIONAL CO.,LTD has been cited for 12 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 OSSIAN INTERNAYIONAL CO.,LTD come from?

All FDA import refusal data for OSSIAN INTERNAYIONAL 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.