Reckitt Benckiser Healthcare International Ltd.
⚠️ High Risk
FEI: 3005656362 • Nottingham • UNITED KINGDOM
FEI Number
3005656362
Location
Nottingham
Country
UNITED KINGDOMAddress
Building D 95, 1 Thane Rd, Nottingham, , United Kingdom
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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2025 | 60MDA06CODEINE SULFATE (ANALGESIC, NARCOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2024 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/22/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/28/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/27/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/14/2022 | 54AGY13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2018 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 473LABELING | Division of Northeast Imports (DNEI) |
| 10/30/2018 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 473LABELING | Division of Northeast Imports (DNEI) |
| 5/22/2017 | 60QDK07LIDOCAINE | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 61HBA99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/1/2016 | 60SBY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/29/2014 | 88LDTREAGENT, GENERAL PURPOSE | 341REGISTERED | New York District Office (NYK-DO) |
| 7/3/2012 | 62UDA08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2010 | 62GAY92FLURBIPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/11/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/11/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Reckitt Benckiser Healthcare International Ltd.'s FDA import refusal history?
Reckitt Benckiser Healthcare International Ltd. (FEI: 3005656362) has 16 FDA import refusal record(s) in our database, spanning from 8/11/2006 to 7/21/2025.
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 International Ltd.'s FEI number is 3005656362.
What types of violations has Reckitt Benckiser Healthcare International Ltd. received?
Reckitt Benckiser Healthcare International Ltd. has been cited for 8 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 International Ltd. come from?
All FDA import refusal data for Reckitt Benckiser Healthcare International 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.