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GUANGZHOU SHIKAI COSMETICS CO LT

Low Risk

FEI: 3016695234 • Guangzhou • CHINA

FEI

FEI Number

3016695234

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

1 And 2 Complied By The, , Guangzhou, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
6/1/2020
Latest Refusal
6/1/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

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.

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.

Refusal History

DateProductViolationsDivision
6/1/2020
62HAL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
3280FRNMFGREG
333LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GUANGZHOU SHIKAI COSMETICS CO LT's FDA import refusal history?

GUANGZHOU SHIKAI COSMETICS CO LT (FEI: 3016695234) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2020 to 6/1/2020.

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. GUANGZHOU SHIKAI COSMETICS CO LT's FEI number is 3016695234.

What types of violations has GUANGZHOU SHIKAI COSMETICS CO LT received?

GUANGZHOU SHIKAI COSMETICS CO LT has been cited for 3 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 SHIKAI COSMETICS CO LT come from?

All FDA import refusal data for GUANGZHOU SHIKAI COSMETICS CO LT 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.