Poskom Co., Ltd.

⚠️ Moderate Risk

FEI: 3005246977 • Kyunggi-Do • SOUTH KOREA

FEI

FEI Number

3005246977

📍

Location

Kyunggi-Do

🇰🇷

Country

SOUTH KOREA

🏢

Address

1141-2, Beaksuk-Dong, Ilsan-Gu, Unitech B/D 404, Koyang-Shi, Kyunggi-Do, , South Korea

Moderate Risk

FDA Import Risk Assessment

40.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/14/2010

Latest Refusal

11/30/2006

Earliest Refusal

Score Breakdown

Violation Severity

62.2×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

32.2×10%

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

4712×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

47611×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

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).

2781×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

3411×

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).

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
12/14/2010	90IZLSYSTEM, X-RAY, MOBILE	118NOT LISTED 278NO TAG 341REGISTERED 508NO 510(K)	Seattle District Office (SEA-DO)
12/3/2007	90IZLSYSTEM, X-RAY, MOBILE	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
12/3/2007	90IZLSYSTEM, X-RAY, MOBILE	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
12/3/2007	90IZLSYSTEM, X-RAY, MOBILE	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
12/3/2007	90IZLSYSTEM, X-RAY, MOBILE	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD 476NO REGISTR	Chicago District Office (CHI-DO)
11/30/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	47NON STD	Chicago District Office (CHI-DO)

Frequently Asked Questions

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

Poskom Co., Ltd. (FEI: 3005246977) has 13 FDA import refusal record(s) in our database, spanning from 11/30/2006 to 12/14/2010.

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. Poskom Co., Ltd.'s FEI number is 3005246977.

What types of violations has Poskom Co., Ltd. received?

Poskom Co., Ltd. has been cited for 6 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 Poskom Co., Ltd. come from?

All FDA import refusal data for Poskom 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.