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Kelly International Cosmetics

✅ Low Risk

FEI: 3006845777 • unknown • INDONESIA

FEI

FEI Number

3006845777

📍

Location

unknown

🇮🇩

Country

INDONESIA
🏢

Address

unknown, , unknown, , Indonesia

Low Risk

FDA Import Risk Assessment

19.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/1/2008
Latest Refusal
10/1/2008
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
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).

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
10/1/2008
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
333LACKS FIRM
335LACKS N/C
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Kelly International Cosmetics's FDA import refusal history?

Kelly International Cosmetics (FEI: 3006845777) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2008 to 10/1/2008.

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. Kelly International Cosmetics's FEI number is 3006845777.

What types of violations has Kelly International Cosmetics received?

Kelly International Cosmetics 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 Kelly International Cosmetics come from?

All FDA import refusal data for Kelly International Cosmetics 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.