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Guangzhou Yida Hairdressing Technology Co., Ltd.

⚠️ Moderate Risk

FEI: 3009156796 • Guangdong • CHINA

FEI

FEI Number

3009156796

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

28 Guangzhou Bai Yun District Yunshan, , Guangdong, , China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
12/1/2011
Latest Refusal
12/1/2011
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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).

5081×

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.

Refusal History

DateProductViolationsDivision
12/1/2011
89ILYLAMP, INFRARED, THERAPEUTIC HEATING
118NOT LISTED
16DIRECTIONS
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Guangzhou Yida Hairdressing Technology Co., Ltd.'s FDA import refusal history?

Guangzhou Yida Hairdressing Technology Co., Ltd. (FEI: 3009156796) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2011 to 12/1/2011.

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. Guangzhou Yida Hairdressing Technology Co., Ltd.'s FEI number is 3009156796.

What types of violations has Guangzhou Yida Hairdressing Technology Co., Ltd. received?

Guangzhou Yida Hairdressing Technology 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 Guangzhou Yida Hairdressing Technology Co., Ltd. come from?

All FDA import refusal data for Guangzhou Yida Hairdressing Technology 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.