Hichance Industries Limited

⚠️ High Risk

FEI: 3012216286 • Yangzhou, Jiangsu • CHINA

FEI

FEI Number

3012216286

📍

Location

Yangzhou, Jiangsu

🇨🇳

Country

CHINA

🏢

Address

No. 1-2 Shuangtang, Ganquan Town, Yangzhou, Jiangsu, China

High Risk

FDA Import Risk Assessment

52.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

5/12/2021

Latest Refusal

8/12/2019

Earliest Refusal

Score Breakdown

Violation Severity

66.5×40%

Refusal Volume

47.4×30%

Recency

6.6×20%

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

4711×

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.

4767×

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).

1266×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

2782×

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).

Refusal History

Date	Product	Violations	Division
5/12/2021	95REJTOY, NOVELTY, PLAY LASER PRODUCT	278NO TAG 47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
4/29/2021	95REJTOY, NOVELTY, PLAY LASER PRODUCT	476NO REGISTR	Division of Northeast Imports (DNEI)
4/27/2021	95REJTOY, NOVELTY, PLAY LASER PRODUCT	278NO TAG 47NON STD 476NO REGISTR	Division of West Coast Imports (DWCI)
5/14/2020	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
1/22/2020	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD	Division of Northeast Imports (DNEI)
12/17/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Northeast Imports (DNEI)
12/2/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Northeast Imports (DNEI)
11/25/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
11/21/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
11/18/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD	Division of Southeast Imports (DSEI)
11/14/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Northern Border Imports (DNBI)
11/13/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of West Coast Imports (DWCI)
11/13/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Southwest Imports (DSWI)
11/13/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	47NON STD	Division of Southwest Imports (DSWI)
11/5/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD 476NO REGISTR	Division of Southeast Imports (DSEI)
11/5/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD 476NO REGISTR	Division of Southeast Imports (DSEI)
11/5/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD 476NO REGISTR	Division of Southeast Imports (DSEI)
8/12/2019	95REJTOY, NOVELTY, PLAY LASER PRODUCT	126FAILS STD 476NO REGISTR	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Hichance Industries Limited's FDA import refusal history?

Hichance Industries Limited (FEI: 3012216286) has 18 FDA import refusal record(s) in our database, spanning from 8/12/2019 to 5/12/2021.

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. Hichance Industries Limited's FEI number is 3012216286.

What types of violations has Hichance Industries Limited received?

Hichance Industries Limited 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 Hichance Industries Limited come from?

All FDA import refusal data for Hichance Industries 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.