TAIHU HUA MEI MEDICAL EQUIPMENT
✅ Low Risk
FEI: 3012792734 • Anqing City • CHINA
FEI Number
3012792734
Location
Anqing City
Country
CHINAAddress
NO 2 Longgang Road, , Anqing City, , China
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 TAIHU HUA MEI MEDICAL EQUIPMENT's FDA import refusal history?
TAIHU HUA MEI MEDICAL EQUIPMENT (FEI: 3012792734) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2016 to 10/21/2016.
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. TAIHU HUA MEI MEDICAL EQUIPMENT's FEI number is 3012792734.
What types of violations has TAIHU HUA MEI MEDICAL EQUIPMENT received?
TAIHU HUA MEI MEDICAL EQUIPMENT 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 TAIHU HUA MEI MEDICAL EQUIPMENT come from?
All FDA import refusal data for TAIHU HUA MEI MEDICAL EQUIPMENT 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.