Godiva Inc
⚠️ High Risk
FEI: 3004513358 • Makati City • PHILIPPINES
FEI Number
3004513358
Location
Makati City
Country
PHILIPPINESAddress
349 Sen Gil Puyat, , Makati City, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2005 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/12/2005 | 62WDY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/12/2005 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/12/2005 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/12/2005 | 53JF01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 64ABY20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBY99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/3/2004 | 65GBR99PIGMENTATION AGENT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Godiva Inc's FDA import refusal history?
Godiva Inc (FEI: 3004513358) has 19 FDA import refusal record(s) in our database, spanning from 6/3/2004 to 5/12/2005.
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. Godiva Inc's FEI number is 3004513358.
What types of violations has Godiva Inc received?
Godiva Inc has been cited for 3 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 Godiva Inc come from?
All FDA import refusal data for Godiva 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.