Laboratorios de Cosmetica Cientifica Atache, S.A.
⚠️ High Risk
FEI: 3006370423 • Alicante, Alicante • SPAIN
FEI Number
3006370423
Location
Alicante, Alicante
Country
SPAINAddress
Calle Sagitario 14, , Alicante, Alicante, Spain
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 66PBL06OCTABENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 11/30/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Laboratorios de Cosmetica Cientifica Atache, S.A.'s FDA import refusal history?
Laboratorios de Cosmetica Cientifica Atache, S.A. (FEI: 3006370423) has 11 FDA import refusal record(s) in our database, spanning from 11/30/2010 to 11/30/2010.
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. Laboratorios de Cosmetica Cientifica Atache, S.A.'s FEI number is 3006370423.
What types of violations has Laboratorios de Cosmetica Cientifica Atache, S.A. received?
Laboratorios de Cosmetica Cientifica Atache, S.A. has been cited for 2 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 Laboratorios de Cosmetica Cientifica Atache, S.A. come from?
All FDA import refusal data for Laboratorios de Cosmetica Cientifica Atache, 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.