Motex International Corp.

⚠️ Moderate Risk

FEI: 3004129254 • Taipei • TAIWAN

FEI

FEI Number

3004129254

📍

Location

Taipei

🇹🇼

Country

TAIWAN

🏢

Address

19f-3, # 508, Chung Hsiao East Road,, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

36.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/1/2005

Latest Refusal

10/2/2003

Earliest Refusal

Score Breakdown

Violation Severity

48.9×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

52.1×10%

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

Violation Summary

3417×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1185×

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

Date	Product	Violations	Division
9/1/2005	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/12/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED	Florida District Office (FLA-DO)
7/1/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
7/1/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	118NOT LISTED	Florida District Office (FLA-DO)
6/23/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
6/23/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/8/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/11/2004	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED	Florida District Office (FLA-DO)
10/6/2003	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/2/2003	80LYYGLOVE, PATIENT EXAMINATION, LATEX	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Motex International Corp.'s FDA import refusal history?

Motex International Corp. (FEI: 3004129254) has 10 FDA import refusal record(s) in our database, spanning from 10/2/2003 to 9/1/2005.

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. Motex International Corp.'s FEI number is 3004129254.

What types of violations has Motex International Corp. received?

Motex International Corp. 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 Motex International Corp. come from?

All FDA import refusal data for Motex International Corp. 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.