In Sung Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3007707641 • Chungbuk • SOUTH KOREA
FEI Number
3007707641
Location
Chungbuk
Country
SOUTH KOREAAddress
9-5 Buyoon-Ri, Daeso-Myun, , Chungbuk, , 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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is In Sung Pharmaceutical Co., Ltd.'s FDA import refusal history?
In Sung Pharmaceutical Co., Ltd. (FEI: 3007707641) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2009 to 12/15/2009.
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. In Sung Pharmaceutical Co., Ltd.'s FEI number is 3007707641.
What types of violations has In Sung Pharmaceutical Co., Ltd. received?
In Sung Pharmaceutical Co., Ltd. has been cited for 4 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 In Sung Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for In Sung 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.