BLS CO
⚠️ Moderate Risk
FEI: 3035557227 • Hwaseong-Si • SOUTH KOREA
FEI Number
3035557227
Location
Hwaseong-Si
Country
SOUTH KOREAAddress
301 302 9-21 Dongtans, , Hwaseong-Si, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is BLS CO's FDA import refusal history?
BLS CO (FEI: 3035557227) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2025 to 3/20/2025.
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. BLS CO's FEI number is 3035557227.
What types of violations has BLS CO received?
BLS CO has been cited for 1 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 BLS CO come from?
All FDA import refusal data for BLS CO 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.