Beauche International
⚠️ High Risk
FEI: 3010218412 • Cavite • PHILIPPINES
FEI Number
3010218412
Location
Cavite
Country
PHILIPPINESAddress
Blk 2, Lot 24 Aguinaldo Hi-Way, Sampaloc, , Cavite, , Philippines
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2016 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/23/2016 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/23/2016 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/23/2016 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/23/2016 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/23/2015 | 64XAY99KERATOLYTIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/23/2015 | 63IAJ99CAUSTIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/23/2015 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 1/23/2015 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | Cincinnati District Office (CIN-DO) | |
| 1/23/2015 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/7/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/7/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/7/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/7/2015 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/7/2015 | 63V02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/7/2015 | 53J99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/10/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/10/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/10/2014 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/10/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2014 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 10/2/2014 | 53J99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/15/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 11/15/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 11/15/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 11/15/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 11/15/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 11/15/2013 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 64XBJ06SALICYLIC ACID (KERATOLYTIC) | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 63VBL02HYDROQUINONE (DEPIGMENTOR) | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 11/8/2013 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Beauche International's FDA import refusal history?
Beauche International (FEI: 3010218412) has 34 FDA import refusal record(s) in our database, spanning from 11/8/2013 to 8/23/2016.
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. Beauche International's FEI number is 3010218412.
What types of violations has Beauche International received?
Beauche International 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 Beauche International come from?
All FDA import refusal data for Beauche International 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.