Kyoung Il Global Co.,Ltd
⚠️ Moderate Risk
FEI: 3005769357 • Gemjeong • SOUTH KOREA
FEI Number
3005769357
Location
Gemjeong
Country
SOUTH KOREAAddress
1018-4 Guseong, Busan, Gemjeong, , South Korea
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
HEALTH C
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 bears an unauthorized nutrient content/health claim.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2007 | 54FBY12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 12/20/2006 | 29AGY21SOFT DRINK, GINSENG, GENSING, NONCARBONATED | Los Angeles District Office (LOS-DO) | |
| 12/20/2006 | 29AGY21SOFT DRINK, GINSENG, GENSING, NONCARBONATED | Los Angeles District Office (LOS-DO) | |
| 10/30/2006 | 29ACY99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/30/2006 | 54ICR99FIBER, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kyoung Il Global Co.,Ltd's FDA import refusal history?
Kyoung Il Global Co.,Ltd (FEI: 3005769357) has 5 FDA import refusal record(s) in our database, spanning from 10/30/2006 to 7/18/2007.
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. Kyoung Il Global Co.,Ltd's FEI number is 3005769357.
What types of violations has Kyoung Il Global Co.,Ltd received?
Kyoung Il Global Co.,Ltd has been cited for 6 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 Kyoung Il Global Co.,Ltd come from?
All FDA import refusal data for Kyoung Il Global 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.