Sara Lee Philippines Inc.
⚠️ Moderate Risk
FEI: 3003174807 • Sucat • PHILIPPINES
FEI Number
3003174807
Location
Sucat
Country
PHILIPPINESAddress
Lot 2-C Dona Irenes St., , Sucat, , Philippines
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/27/2005 | 66VL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/25/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/25/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/25/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/25/2004 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/14/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/14/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/14/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2003 | 61HBJ99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2003 | 61HBJ99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2003 | 61HBJ99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2003 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sara Lee Philippines Inc.'s FDA import refusal history?
Sara Lee Philippines Inc. (FEI: 3003174807) has 13 FDA import refusal record(s) in our database, spanning from 6/30/2003 to 12/27/2005.
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 Philippines Inc.'s FEI number is 3003174807.
What types of violations has Sara Lee Philippines Inc. received?
Sara Lee Philippines Inc. has been cited for 1 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 Philippines Inc. come from?
All FDA import refusal data for Sara Lee Philippines Inc. 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.