Nathan Trading Co., Ltd.

⚠️ High Risk

FEI: 3012099156 • Khemarat, Ubon Ratchathani • THAILAND

FEI

FEI Number

3012099156

📍

Location

Khemarat, Ubon Ratchathani

🇹🇭

Country

THAILAND

🏢

Address

Moo 12, 58 Palan Sub-District, Khemarat, Ubon Ratchathani, Thailand

High Risk

FDA Import Risk Assessment

52.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/22/2023

Latest Refusal

10/19/2022

Earliest Refusal

Score Breakdown

Violation Severity

52.6×40%

Refusal Volume

44.6×30%

Recency

41.9×20%

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

50815×

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.

34111×

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).

32805×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
2/22/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)
2/22/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)
2/22/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
1/23/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
10/19/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
10/19/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
10/19/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
10/19/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
10/19/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Nathan Trading Co., Ltd.'s FDA import refusal history?

Nathan Trading Co., Ltd. (FEI: 3012099156) has 15 FDA import refusal record(s) in our database, spanning from 10/19/2022 to 2/22/2023.

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. Nathan Trading Co., Ltd.'s FEI number is 3012099156.

What types of violations has Nathan Trading Co., Ltd. received?

Nathan Trading 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 Nathan Trading Co., Ltd. come from?

All FDA import refusal data for Nathan Trading 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.