Reckitt Benkiser Ltd
⚠️ Moderate Risk
FEI: 3003740869 • Swindon • UNITED KINGDOM
FEI Number
3003740869
Location
Swindon
Country
UNITED KINGDOMAddress
Delta 1200 Welton Road, , Swindon, , United Kingdom
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
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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2011 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | Los Angeles District Office (LOS-DO) | |
| 11/2/2011 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | Los Angeles District Office (LOS-DO) | |
| 1/31/2011 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/10/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/2/2009 | 61FBL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/2/2009 | 61FBL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/17/2009 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | Los Angeles District Office (LOS-DO) | |
| 9/17/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/17/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/14/2009 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 7/14/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 3/3/2009 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 3/2/2009 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/17/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/10/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 64ABI99DISINFECTANT N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 61FAL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 61FAL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 61FKK21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 12/9/2008 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 10/14/2008 | 66VAU99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/8/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 8/8/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 8/7/2008 | 61FBL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 8/5/2008 | 53SY01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | Los Angeles District Office (LOS-DO) | |
| 5/21/2008 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 66VAU99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 61FAL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 4/19/2008 | 61FKK21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/11/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 4/1/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 3/20/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/28/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/17/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/27/2007 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/27/2007 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/19/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Reckitt Benkiser Ltd's FDA import refusal history?
Reckitt Benkiser Ltd (FEI: 3003740869) has 41 FDA import refusal record(s) in our database, spanning from 9/19/2003 to 12/15/2011.
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 Benkiser Ltd's FEI number is 3003740869.
What types of violations has Reckitt Benkiser Ltd received?
Reckitt Benkiser 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 Benkiser Ltd come from?
All FDA import refusal data for Reckitt Benkiser 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.