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Guangdong Essence Daily Chemical Co., Ltd.

⚠️ Moderate Risk

FEI: 3009135201 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3009135201

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.63, Guoya Road, Shenshan Administrative Area, Jianggao Town, Baiyun District, Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

27.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
6
Unique Violations
11/12/2020
Latest Refusal
10/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
45.6×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32803×

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.

1182×

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

38961×

NOCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
11/12/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
3280FRNMFGREG
333LACKS FIRM
336INCONSPICU
3896NOCONTACT
483DRUG NAME
Division of Northeast Imports (DNEI)
11/2/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3280FRNMFGREG
Division of Northeast Imports (DNEI)
10/23/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Guangdong Essence Daily Chemical Co., Ltd.'s FDA import refusal history?

Guangdong Essence Daily Chemical Co., Ltd. (FEI: 3009135201) has 3 FDA import refusal record(s) in our database, spanning from 10/23/2020 to 11/12/2020.

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. Guangdong Essence Daily Chemical Co., Ltd.'s FEI number is 3009135201.

What types of violations has Guangdong Essence Daily Chemical Co., Ltd. received?

Guangdong Essence Daily Chemical Co., Ltd. has been cited for 6 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 Guangdong Essence Daily Chemical Co., Ltd. come from?

All FDA import refusal data for Guangdong Essence Daily Chemical 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.