Pierre Fabre Cosmetique
⚠️ High Risk
FEI: 3002609688 • Boulogne-Paris • FRANCE
FEI Number
3002609688
Location
Boulogne-Paris
Country
FRANCEAddress
45, Place Abel Gance, , Boulogne-Paris, , France
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).
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.
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2025 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 3/9/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2020 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/15/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/5/2015 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/23/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Philadelphia District Office (PHI-DO) | |
| 8/10/2012 | 64NAA06FERROUS SULFATE (HEMATINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 53ID99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2011 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Philadelphia District Office (PHI-DO) |
| 11/22/2011 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Philadelphia District Office (PHI-DO) |
| 11/22/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/22/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/22/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/25/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/10/2003 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Pierre Fabre Cosmetique's FDA import refusal history?
Pierre Fabre Cosmetique (FEI: 3002609688) has 16 FDA import refusal record(s) in our database, spanning from 12/10/2003 to 10/30/2025.
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. Pierre Fabre Cosmetique's FEI number is 3002609688.
What types of violations has Pierre Fabre Cosmetique received?
Pierre Fabre Cosmetique 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 Pierre Fabre Cosmetique come from?
All FDA import refusal data for Pierre Fabre Cosmetique 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.