HAMSOA PHARMACEUTICAL CO., LTD.
⚠️ Moderate Risk
FEI: 3010164539 • Seoul, Seoul • SOUTH KOREA
FEI Number
3010164539
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
228, Dosan-daero, Gangnam-gu, , Seoul, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2011 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 4/21/2009 | 54ACA99VITAMIN, N.E.C. | 238UNSAFE ADD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is HAMSOA PHARMACEUTICAL CO., LTD.'s FDA import refusal history?
HAMSOA PHARMACEUTICAL CO., LTD. (FEI: 3010164539) has 16 FDA import refusal record(s) in our database, spanning from 4/21/2009 to 10/21/2011.
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. HAMSOA PHARMACEUTICAL CO., LTD.'s FEI number is 3010164539.
What types of violations has HAMSOA PHARMACEUTICAL CO., LTD. received?
HAMSOA PHARMACEUTICAL CO., LTD. has been cited for 3 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 HAMSOA PHARMACEUTICAL CO., LTD. come from?
All FDA import refusal data for HAMSOA PHARMACEUTICAL 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.