SURGI BIO CO LTD
✅ Low Risk
FEI: 3015300254 • Seongnam Si • SOUTH KOREA
FEI Number
3015300254
Location
Seongnam Si
Country
SOUTH KOREAAddress
407 Suntechcity, , Seongnam Si, , South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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
Frequently Asked Questions
What is SURGI BIO CO LTD's FDA import refusal history?
SURGI BIO CO LTD (FEI: 3015300254) has 1 FDA import refusal record(s) in our database, spanning from 5/29/2019 to 5/29/2019.
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. SURGI BIO CO LTD's FEI number is 3015300254.
What types of violations has SURGI BIO CO LTD received?
SURGI BIO 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 SURGI BIO CO LTD come from?
All FDA import refusal data for SURGI BIO 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.