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SANBO MEDICAL EQUIPMENT CO LTD

Low Risk

FEI: 3018097495 • Guangzhou • CHINA

FEI

FEI Number

3018097495

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

Tianyian Road Baiyun Di, , Guangzhou, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/13/2021
Latest Refusal
4/13/2021
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
4/13/2021
53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SANBO MEDICAL EQUIPMENT CO LTD's FDA import refusal history?

SANBO MEDICAL EQUIPMENT CO LTD (FEI: 3018097495) has 1 FDA import refusal record(s) in our database, spanning from 4/13/2021 to 4/13/2021.

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. SANBO MEDICAL EQUIPMENT CO LTD's FEI number is 3018097495.

What types of violations has SANBO MEDICAL EQUIPMENT CO LTD received?

SANBO MEDICAL EQUIPMENT 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 SANBO MEDICAL EQUIPMENT CO LTD come from?

All FDA import refusal data for SANBO MEDICAL EQUIPMENT 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.