Sara Lee Household & Body Care
⚠️ Moderate Risk
FEI: 3001072883 • Slough, SLG • UNITED KINGDOM
FEI Number
3001072883
Location
Slough, SLG
Country
UNITED KINGDOMAddress
225 Bath Road, , Slough, SLG, 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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/14/2008 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/8/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 5/12/2008 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 5/12/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/19/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/11/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 4/1/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 4/1/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 335LACKS N/C | Los Angeles District Office (LOS-DO) |
| 4/1/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/20/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 1/28/2008 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/27/2007 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/21/2002 | 55YG99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sara Lee Household & Body Care's FDA import refusal history?
Sara Lee Household & Body Care (FEI: 3001072883) has 16 FDA import refusal record(s) in our database, spanning from 6/21/2002 to 12/9/2008.
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. Sara Lee Household & Body Care's FEI number is 3001072883.
What types of violations has Sara Lee Household & Body Care received?
Sara Lee Household & Body Care 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 Sara Lee Household & Body Care come from?
All FDA import refusal data for Sara Lee Household & Body Care 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.