Tae-Chang Industrial Co., Ltd.

⚠️ High Risk

FEI: 3011676762 • Gumi, Gyeongsangbuk • SOUTH KOREA

FEI

FEI Number

3011676762

📍

Location

Gumi, Gyeongsangbuk

🇰🇷

Country

SOUTH KOREA

🏢

Address

127 Sanhodae-Ro, , Gumi, Gyeongsangbuk, South Korea

High Risk

FDA Import Risk Assessment

67.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

2/17/2023

Latest Refusal

10/18/2022

Earliest Refusal

Score Breakdown

Violation Severity

74.4×40%

Refusal Volume

64.8×30%

Recency

42.0×20%

Frequency

100.0×10%

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

Violation Summary

50845×

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.

23732×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

23803×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

Date	Product	Violations	Division
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2023	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/21/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	2380NO PMA/PDP	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	2380NO PMA/PDP	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	2380NO PMA/PDP	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/19/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2022	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Tae-Chang Industrial Co., Ltd.'s FDA import refusal history?

Tae-Chang Industrial Co., Ltd. (FEI: 3011676762) has 55 FDA import refusal record(s) in our database, spanning from 10/18/2022 to 2/17/2023.

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. Tae-Chang Industrial Co., Ltd.'s FEI number is 3011676762.

What types of violations has Tae-Chang Industrial Co., Ltd. received?

Tae-Chang Industrial 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 Tae-Chang Industrial Co., Ltd. come from?

All FDA import refusal data for Tae-Chang Industrial 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.