Pt Mandom Indonesia Tbk
⚠️ Moderate Risk
FEI: 3003350259 • Jakarta • INDONESIA
FEI Number
3003350259
Location
Jakarta
Country
INDONESIAAddress
Jl. Yos Sudarso Pass.P.O. Box 1072, , Jakarta, , Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2015 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 10/14/2015 | 53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | Minneapolis District Office (MIN-DO) | |
| 11/10/2014 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/31/2014 | 53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/13/2012 | 53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 50NMY18HENNA | 321LACKS N/C | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 50NMY18HENNA | 321LACKS N/C | New Orleans District Office (NOL-DO) |
| 5/30/2012 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 5/22/2012 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 12/9/2011 | 53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pt Mandom Indonesia Tbk's FDA import refusal history?
Pt Mandom Indonesia Tbk (FEI: 3003350259) has 10 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 12/8/2015.
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. Pt Mandom Indonesia Tbk's FEI number is 3003350259.
What types of violations has Pt Mandom Indonesia Tbk received?
Pt Mandom Indonesia Tbk 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 Pt Mandom Indonesia Tbk come from?
All FDA import refusal data for Pt Mandom Indonesia Tbk 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.