YS Life Science Co., Ltd.
⚠️ Moderate Risk
FEI: 3005877120 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3005877120
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
207 Sujeong-Ro, Jangan-Myeon, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2023 | 62CCS70TREPROSTINIL SODIUM | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 4/21/2023 | 62CCS70TREPROSTINIL SODIUM | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/26/2014 | 62JCS12CABERGOLINE (ANTI-PARKINSONIAN) | Florida District Office (FLA-DO) | |
| 9/26/2014 | 62JCS12CABERGOLINE (ANTI-PARKINSONIAN) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is YS Life Science Co., Ltd.'s FDA import refusal history?
YS Life Science Co., Ltd. (FEI: 3005877120) has 4 FDA import refusal record(s) in our database, spanning from 9/26/2014 to 4/21/2023.
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. YS Life Science Co., Ltd.'s FEI number is 3005877120.
What types of violations has YS Life Science Co., Ltd. received?
YS Life Science 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 YS Life Science Co., Ltd. come from?
All FDA import refusal data for YS Life Science 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.