Reckitt Benckiser Indonesia
⚠️ Moderate Risk
FEI: 3006848525 • Jakarta, Jabotabek • INDONESIA
FEI Number
3006848525
Location
Jakarta, Jabotabek
Country
INDONESIAAddress
Jln. Boulevard Artha Gading, , Jakarta, Jabotabek, 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
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/13/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 12/9/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Reckitt Benckiser Indonesia's FDA import refusal history?
Reckitt Benckiser Indonesia (FEI: 3006848525) has 12 FDA import refusal record(s) in our database, spanning from 12/9/2010 to 9/6/2012.
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. Reckitt Benckiser Indonesia's FEI number is 3006848525.
What types of violations has Reckitt Benckiser Indonesia received?
Reckitt Benckiser Indonesia has been cited for 5 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 Reckitt Benckiser Indonesia come from?
All FDA import refusal data for Reckitt Benckiser Indonesia 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.