Bmtech Worldwide Co., Ltd.
⚠️ Moderate Risk
FEI: 3006119170 • Seongnam-City • SOUTH KOREA
FEI Number
3006119170
Location
Seongnam-City
Country
SOUTH KOREAAddress
10fl,Jungang Induspia 5th 138-6, , Jungwon-Gu, Seongnam-City, , 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
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
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.
Refusal History
Frequently Asked Questions
What is Bmtech Worldwide Co., Ltd.'s FDA import refusal history?
Bmtech Worldwide Co., Ltd. (FEI: 3006119170) has 1 FDA import refusal record(s) in our database, spanning from 4/12/2007 to 4/12/2007.
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. Bmtech Worldwide Co., Ltd.'s FEI number is 3006119170.
What types of violations has Bmtech Worldwide Co., Ltd. received?
Bmtech Worldwide 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 Bmtech Worldwide Co., Ltd. come from?
All FDA import refusal data for Bmtech Worldwide 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.