Zibo Yinghao Medical Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3008386557 • Zibo • CHINA

FEI

FEI Number

3008386557

📍

Location

Zibo

🇨🇳

Country

CHINA

🏢

Address

Technology Industry Park, NO. 6 Yifan Road, Zibo, , China

Moderate Risk

FDA Import Risk Assessment

47.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/18/2020

Latest Refusal

1/11/2011

Earliest Refusal

Score Breakdown

Violation Severity

67.7×40%

Refusal Volume

56.2×30%

Recency

0.0×20%

Frequency

34.8×10%

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

47731×

HOLES

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

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).

32801×

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.

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).

Refusal History

Date	Product	Violations	Division
3/18/2020	80OPIANTIMICROBIAL MEDICAL GLOVE	118NOT LISTED 3280FRNMFGREG	Division of West Coast Imports (DWCI)
3/18/2019	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 477HOLES	Division of Southeast Imports (DSEI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
10/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
9/4/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
9/4/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
9/4/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
9/4/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
9/4/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
7/27/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
7/27/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
7/23/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/29/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/29/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/29/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/29/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/29/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
6/20/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northeast Imports (DNEI)
6/20/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northeast Imports (DNEI)
6/20/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Northeast Imports (DNEI)
5/23/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of Southwest Imports (DSWI)
3/29/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
2/18/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)
2/11/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)
2/7/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
1/13/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)
1/13/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)
1/11/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)

Frequently Asked Questions

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

Zibo Yinghao Medical Products Co., Ltd. (FEI: 3008386557) has 32 FDA import refusal record(s) in our database, spanning from 1/11/2011 to 3/18/2020.

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 Yinghao Medical Products Co., Ltd.'s FEI number is 3008386557.

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

Zibo Yinghao Medical Products Co., Ltd. has been cited for 4 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 Yinghao Medical Products Co., Ltd. come from?

All FDA import refusal data for Zibo Yinghao 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.