Kwang Dong Pharm. Co., Ltd
⚠️ Moderate Risk
FEI: 1000154218 • Seoul • SOUTH KOREA
FEI Number
1000154218
Location
Seoul
Country
SOUTH KOREAAddress
212-13 Guro-Gu Guro Dong, , Seoul, , 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2010 | 29AGT02SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED | 238UNSAFE ADD | San Francisco District Office (SAN-DO) |
| 5/22/2002 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/22/2002 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/22/2002 | 29ACT03SOFT DRINK, CORE FRUIT FLAVORED, NONCARBONATED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/22/2002 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/22/2002 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kwang Dong Pharm. Co., Ltd's FDA import refusal history?
Kwang Dong Pharm. Co., Ltd (FEI: 1000154218) has 6 FDA import refusal record(s) in our database, spanning from 5/22/2002 to 5/24/2010.
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. Kwang Dong Pharm. Co., Ltd's FEI number is 1000154218.
What types of violations has Kwang Dong Pharm. Co., Ltd received?
Kwang Dong Pharm. Co., Ltd has been cited for 2 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 Kwang Dong Pharm. Co., Ltd come from?
All FDA import refusal data for Kwang Dong Pharm. 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.