Productos Capilares L'oreal S.A.
✅ Low Risk
FEI: 2000044896 • Burgos, Burgos • SPAIN
FEI Number
2000044896
Location
Burgos, Burgos
Country
SPAINAddress
Calle Lopez Bravo 78, Poligono Industrial Villalonqu, Burgos, Burgos, Spain
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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
Frequently Asked Questions
What is Productos Capilares L'oreal S.A.'s FDA import refusal history?
Productos Capilares L'oreal S.A. (FEI: 2000044896) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 5/26/2011.
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. Productos Capilares L'oreal S.A.'s FEI number is 2000044896.
What types of violations has Productos Capilares L'oreal S.A. received?
Productos Capilares L'oreal 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 Productos Capilares L'oreal S.A. come from?
All FDA import refusal data for Productos Capilares L'oreal 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.