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A Spine Asia Co., Ltd.

⚠️ Moderate Risk

FEI: 3008959623 • Taipei City • TAIWAN

FEI

FEI Number

3008959623

📍

Location

Taipei City

🇹🇼

Country

TAIWAN
🏢

Address

11fl, No.1, Alley 30, Lane 358,, , Taipei City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/10/2014
Latest Refusal
1/10/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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.

Refusal History

DateProductViolationsDivision
1/10/2014
87MAXORTHOSIS, SPINAL INTERVERTEBRAL FUSION
2780DEVICEGMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is A Spine Asia Co., Ltd.'s FDA import refusal history?

A Spine Asia Co., Ltd. (FEI: 3008959623) has 1 FDA import refusal record(s) in our database, spanning from 1/10/2014 to 1/10/2014.

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. A Spine Asia Co., Ltd.'s FEI number is 3008959623.

What types of violations has A Spine Asia Co., Ltd. received?

A Spine Asia 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 A Spine Asia Co., Ltd. come from?

All FDA import refusal data for A Spine Asia 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.