Shandong Intco Medical Products Co., Ltd

⚠️ High Risk

FEI: 3011391433 • Qingzhou, Shandong • CHINA

FEI

FEI Number

3011391433

📍

Location

Qingzhou, Shandong

🇨🇳

Country

CHINA

🏢

Address

Naoshan Industrial Park, 9888 Qiwang Road, Qingzhou, Shandong, China

High Risk

FDA Import Risk Assessment

68.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/9/2024

Latest Refusal

12/7/2022

Earliest Refusal

Score Breakdown

Violation Severity

65.0×40%

Refusal Volume

60.9×30%

Recency

73.0×20%

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

47722×

HOLES

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

50814×

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.

32809×

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.

1184×

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).

27803×

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.

Refusal History

Date	Product	Violations	Division
9/9/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
8/23/2024	80FMCGLOVE, PATIENT EXAMINATION	118NOT LISTED 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)
1/24/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/22/2024	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/29/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/17/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/17/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/3/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/3/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/3/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/3/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
10/24/2023	80LYZGLOVE, PATIENT EXAMINATION, VINYL	508NO 510(K)	Division of Northern Border Imports (DNBI)
10/4/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
9/20/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/20/2023	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/19/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
9/19/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
9/19/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/19/2023	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/19/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/19/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
4/6/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	2780DEVICEGMPS 477HOLES	Division of Northern Border Imports (DNBI)
4/3/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	2780DEVICEGMPS 477HOLES	Division of Northern Border Imports (DNBI)
3/21/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
3/16/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/16/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/14/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/9/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/7/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
3/7/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
3/7/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/7/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
3/7/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
3/2/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	2780DEVICEGMPS	Division of Northern Border Imports (DNBI)
3/2/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
2/17/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
2/15/2023	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	477HOLES	Division of Northern Border Imports (DNBI)
2/15/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
2/15/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
2/15/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
1/31/2023	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northern Border Imports (DNBI)
12/7/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Shandong Intco Medical Products Co., Ltd's FDA import refusal history?

Shandong Intco Medical Products Co., Ltd (FEI: 3011391433) has 43 FDA import refusal record(s) in our database, spanning from 12/7/2022 to 9/9/2024.

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. Shandong Intco Medical Products Co., Ltd's FEI number is 3011391433.

What types of violations has Shandong Intco Medical Products Co., Ltd received?

Shandong Intco Medical Products Co., Ltd has been cited for 5 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 Shandong Intco Medical Products Co., Ltd come from?

All FDA import refusal data for Shandong Intco Medical Products 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.