Minghao Medical Products Co., Ltd.

⚠️ High Risk

FEI: 3012984376 • Tangshan, Hebei • CHINA

FEI

FEI Number

3012984376

📍

Location

Tangshan, Hebei

🇨🇳

Country

CHINA

🏢

Address

West Industrial Park, Luannan County, Tangshan, Hebei, China

High Risk

FDA Import Risk Assessment

62.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/6/2023

Latest Refusal

8/23/2022

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

51.8×30%

Recency

44.3×20%

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

47724×

HOLES

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

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
4/6/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
4/6/2023	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northeast Imports (DNEI)
11/1/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
10/6/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
10/6/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
10/6/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
10/4/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
10/3/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
10/3/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
9/23/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
9/15/2022	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northern Border Imports (DNBI)
9/15/2022	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northern Border Imports (DNBI)
9/15/2022	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northern Border Imports (DNBI)
9/15/2022	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northern Border Imports (DNBI)
9/12/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Northern Border Imports (DNBI)
9/9/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
9/9/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
9/9/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
8/25/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
8/25/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
8/25/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of West Coast Imports (DWCI)
8/23/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	2780DEVICEGMPS 477HOLES	Division of Northeast Imports (DNEI)
8/23/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	2780DEVICEGMPS 477HOLES	Division of Northeast Imports (DNEI)
8/23/2022	80LZAGLOVE, PATIENT EXAMINATION, POLY	2780DEVICEGMPS 477HOLES	Division of Northeast Imports (DNEI)

Frequently Asked Questions

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

Minghao Medical Products Co., Ltd. (FEI: 3012984376) has 24 FDA import refusal record(s) in our database, spanning from 8/23/2022 to 4/6/2023.

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. Minghao Medical Products Co., Ltd.'s FEI number is 3012984376.

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

Minghao Medical Products Co., Ltd. has been cited for 2 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 Minghao Medical Products Co., Ltd. come from?

All FDA import refusal data for Minghao 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.