Reckitt Benckiser (India) Pvt. Ltd.
⚠️ High Risk
FEI: 3015154386 • Sitarganj, Uttarakhand • INDIA
FEI Number
3015154386
Location
Sitarganj, Uttarakhand
Country
INDIAAddress
Unit Ii, Ml No M 15/C/Ua/2015, Sitarganj, Uttarakhand, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2024 | 53KC05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/29/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 11/24/2020 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of West Coast Imports (DWCI) | |
| 1/30/2019 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Reckitt Benckiser (India) Pvt. Ltd.'s FDA import refusal history?
Reckitt Benckiser (India) Pvt. Ltd. (FEI: 3015154386) has 5 FDA import refusal record(s) in our database, spanning from 1/30/2019 to 9/11/2024.
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 (India) Pvt. Ltd.'s FEI number is 3015154386.
What types of violations has Reckitt Benckiser (India) Pvt. Ltd. received?
Reckitt Benckiser (India) Pvt. Ltd. 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 (India) Pvt. Ltd. come from?
All FDA import refusal data for Reckitt Benckiser (India) Pvt. 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.