Reckitt Benckiser Healthcare
⚠️ High Risk
FEI: 3007903677 • Baddi, Himachal Pradesh • INDIA
FEI Number
3007903677
Location
Baddi, Himachal Pradesh
Country
INDIAAddress
No 701/534 Nalagrah Road, , Baddi, Himachal Pradesh, 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).
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).
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
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 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/10/2025 | 62HBL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/10/2025 | 62HBO99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 10/11/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/3/2024 | 61WBO18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 1/16/2024 | 61WBJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 1/16/2024 | 66FDG99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/13/2023 | 64AAY99DISINFECTANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/2/2022 | 62GDB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2019 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/1/2018 | 61WCJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northern Border Imports (DNBI) | |
| 12/16/2016 | 62UBA99ANTI-TUSSIVE/COLD N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 12/15/2016 | 62GAJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/11/2014 | 65QBY99RELAXANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/28/2014 | 65LBO15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | New England District Office (NWE-DO) | |
| 3/28/2014 | 62GCJ99ANTI-INFLAMMATORY N.E.C. | New England District Office (NWE-DO) | |
| 4/4/2013 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/2/2012 | 60QBJ99ANESTHETIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/26/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
| 6/14/2011 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Reckitt Benckiser Healthcare's FDA import refusal history?
Reckitt Benckiser Healthcare (FEI: 3007903677) has 20 FDA import refusal record(s) in our database, spanning from 6/14/2011 to 5/29/2025.
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 Healthcare's FEI number is 3007903677.
What types of violations has Reckitt Benckiser Healthcare received?
Reckitt Benckiser Healthcare has been cited for 7 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 Healthcare come from?
All FDA import refusal data for Reckitt Benckiser Healthcare 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.