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Dalian Goodwood Medical Care Ltd

⚠️ Moderate Risk

FEI: 3007517215 • Dalian, Liaoning • CHINA

FEI

FEI Number

3007517215

📍

Location

Dalian, Liaoning

🇨🇳

Country

CHINA
🏢

Address

3, 91 Yongzheng Street; Jinzhou District, Dalian, Liaoning, China

Moderate Risk

FDA Import Risk Assessment

39.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
12/14/2017
Latest Refusal
3/23/2012
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.5×10%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

28001×

POSS N/STR

The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms

Refusal History

DateProductViolationsDivision
12/14/2017
85HHTSPATULA, CERVICAL, CYTOLOGICAL
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
3/23/2012
80LRJDISINFECTANT, MEDICAL DEVICES
2800POSS N/STR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dalian Goodwood Medical Care Ltd's FDA import refusal history?

Dalian Goodwood Medical Care Ltd (FEI: 3007517215) has 2 FDA import refusal record(s) in our database, spanning from 3/23/2012 to 12/14/2017.

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. Dalian Goodwood Medical Care Ltd's FEI number is 3007517215.

What types of violations has Dalian Goodwood Medical Care Ltd received?

Dalian Goodwood Medical Care Ltd has been cited for 2 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 Dalian Goodwood Medical Care Ltd come from?

All FDA import refusal data for Dalian Goodwood Medical Care 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.