Investigacion y Dearrollo de Cosmeticos,S.A
⚠️ Moderate Risk
FEI: 1000393800 • Barcelona, Barcelona • SPAIN
FEI Number
1000393800
Location
Barcelona, Barcelona
Country
SPAINAddress
Carrer De La Costa Brava 305, , Barcelona, Barcelona, Spain
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
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 |
|---|---|---|---|
| 5/14/2007 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/10/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/22/2006 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 10/18/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Juan District Office (SJN-DO) | |
| 8/11/2005 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/5/2003 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Investigacion y Dearrollo de Cosmeticos,S.A's FDA import refusal history?
Investigacion y Dearrollo de Cosmeticos,S.A (FEI: 1000393800) has 9 FDA import refusal record(s) in our database, spanning from 11/5/2003 to 5/14/2007.
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. Investigacion y Dearrollo de Cosmeticos,S.A's FEI number is 1000393800.
What types of violations has Investigacion y Dearrollo de Cosmeticos,S.A received?
Investigacion y Dearrollo de Cosmeticos,S.A 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 Investigacion y Dearrollo de Cosmeticos,S.A come from?
All FDA import refusal data for Investigacion y Dearrollo de Cosmeticos,S.A 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.