I-MING SANITARY MATERIALS CO., LTD.

⚠️ Moderate Risk

FEI: 3004755469 • Changhua • TAIWAN

FEI

FEI Number

3004755469

📍

Location

Changhua

🇹🇼

Country

TAIWAN

🏢

Address

No. 68 Sec 2, Zhongke Erlin Blvd., Meifang Vil., Erlin Township, Changhua, , Taiwan

Moderate Risk

FDA Import Risk Assessment

31.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/31/2007

Latest Refusal

12/5/2005

Earliest Refusal

Score Breakdown

Violation Severity

35.0×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

57.8×10%

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

34110×

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).

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).

5081×

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.

Refusal History

Date	Product	Violations	Division
10/31/2007	89IRDJOINT, ELBOW, EXTERNAL LIMB COMPONENT, MECHANICAL	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	80FQLSTOCKING, MEDICAL SUPPORT	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	80FQMBANDAGE, ELASTIC	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	89IQJSPLINT, CLAVICAL	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	89ILISLING, ARM	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	78EXNSUPPORT, HERNIA	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	89IQKORTHOSIS, CERVICAL	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	89ITWJOINT, ANKLE, EXTERNAL BRACE	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	89ITQJOINT, KNEE, EXTERNAL BRACE	341REGISTERED	Florida District Office (FLA-DO)
10/31/2007	80KMOBINDER, ELASTIC	341REGISTERED	Florida District Office (FLA-DO)
12/5/2005	89IRTPAD, HEATING, POWERED	118NOT LISTED 508NO 510(K)	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is I-MING SANITARY MATERIALS CO., LTD.'s FDA import refusal history?

I-MING SANITARY MATERIALS CO., LTD. (FEI: 3004755469) has 11 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 10/31/2007.

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. I-MING SANITARY MATERIALS CO., LTD.'s FEI number is 3004755469.

What types of violations has I-MING SANITARY MATERIALS CO., LTD. received?

I-MING SANITARY MATERIALS 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 I-MING SANITARY MATERIALS CO., LTD. come from?

All FDA import refusal data for I-MING SANITARY MATERIALS 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.