ImportRefusal LogoImportRefusal

BLOOMDEN BIOCERAMICS (HUNAN) CO LTD

✅ Low Risk

FEI: 3009643402 • Changsha, Hunan • CHINA

FEI

FEI Number

3009643402

📍

Location

Changsha, Hunan

🇨🇳

Country

CHINA
🏢

Address

No. 301 5th Building, Hi-Tech Int'L Enterprise Port, Liandong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha, Hunan, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/13/2012
Latest Refusal
11/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

Refusal History

DateProductViolationsDivision
11/13/2012
76EIHPOWDER, PORCELAIN
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is BLOOMDEN BIOCERAMICS (HUNAN) CO LTD's FDA import refusal history?

BLOOMDEN BIOCERAMICS (HUNAN) CO LTD (FEI: 3009643402) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 11/13/2012.

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. BLOOMDEN BIOCERAMICS (HUNAN) CO LTD's FEI number is 3009643402.

What types of violations has BLOOMDEN BIOCERAMICS (HUNAN) CO LTD received?

BLOOMDEN BIOCERAMICS (HUNAN) CO LTD 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 BLOOMDEN BIOCERAMICS (HUNAN) CO LTD come from?

All FDA import refusal data for BLOOMDEN BIOCERAMICS (HUNAN) 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.