Zibo Intco Medical Products Company Limited

⚠️ High Risk

FEI: 3008191396 • Zibo, Shandong • CHINA

FEI

FEI Number

3008191396

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA

🏢

Address

18 Qingtian Road, Qilu Chem. Ind. Park, Linzi, , Zibo, Shandong, China

High Risk

FDA Import Risk Assessment

60.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/19/2024

Latest Refusal

2/28/2011

Earliest Refusal

Score Breakdown

Violation Severity

59.0×40%

Refusal Volume

61.2×30%

Recency

76.9×20%

Frequency

32.0×10%

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

11825×

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).

50822×

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.

328017×

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.

47716×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

39051×

3905

Refusal History

Date	Product	Violations	Division
11/19/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	118NOT LISTED 39053905 477HOLES 508NO 510(K)	Division of West Coast Imports (DWCI)
9/17/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	118NOT LISTED 477HOLES 508NO 510(K)	Division of West Coast Imports (DWCI)
2/27/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/27/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/27/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/27/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/27/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/13/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
2/13/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
2/13/2024	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northern Border Imports (DNBI)
2/9/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/1/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/24/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/24/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/17/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/17/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/17/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/17/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/12/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/12/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/7/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	2780DEVICEGMPS 477HOLES	Division of Northern Border Imports (DNBI)
11/3/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
10/24/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
9/14/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
9/14/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
8/18/2022	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
6/15/2017	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southeast Imports (DSEI)
6/15/2017	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
6/15/2017	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
6/15/2017	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southeast Imports (DSEI)
4/5/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Southwest Import District Office (SWI-DO)
2/28/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Zibo Intco Medical Products Company Limited's FDA import refusal history?

Zibo Intco Medical Products Company Limited (FEI: 3008191396) has 44 FDA import refusal record(s) in our database, spanning from 2/28/2011 to 11/19/2024.

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. Zibo Intco Medical Products Company Limited's FEI number is 3008191396.

What types of violations has Zibo Intco Medical Products Company Limited received?

Zibo Intco Medical Products Company Limited 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 Zibo Intco Medical Products Company Limited come from?

All FDA import refusal data for Zibo Intco Medical Products Company Limited 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.