Samsung Pharm Ind. Co., Ltd.
⚠️ Moderate Risk
FEI: 3004371761 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3004371761
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
Hyangnam-Eub, 35 Jeyakgongdan2-Gil; Hyangnam-Eup, Hwaseong, Gyeonggi, 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
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).
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.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2005 | 54FCL12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/12/2005 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/12/2005 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/7/2004 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Samsung Pharm Ind. Co., Ltd.'s FDA import refusal history?
Samsung Pharm Ind. Co., Ltd. (FEI: 3004371761) has 5 FDA import refusal record(s) in our database, spanning from 6/7/2004 to 10/19/2005.
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. Samsung Pharm Ind. Co., Ltd.'s FEI number is 3004371761.
What types of violations has Samsung Pharm Ind. Co., Ltd. received?
Samsung Pharm Ind. Co., Ltd. has been cited for 5 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 Samsung Pharm Ind. Co., Ltd. come from?
All FDA import refusal data for Samsung Pharm Ind. 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.