Colep Consumer Products Portugal, S.A.
⚠️ Moderate Risk
FEI: 3029669126 • Vale De Cambra, Aveiro • PORTUGAL
FEI Number
3029669126
Location
Vale De Cambra, Aveiro
Country
PORTUGALAddress
Rua Comendador Arlindo Soares De Pinho, 1977 Lugar de Lordelo Uniao das Freguesias de Vila Cha Codal e Vila Cova de Perrinho, Vale De Cambra, Aveiro, Portugal
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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.
Refusal History
Frequently Asked Questions
What is Colep Consumer Products Portugal, S.A.'s FDA import refusal history?
Colep Consumer Products Portugal, S.A. (FEI: 3029669126) has 1 FDA import refusal record(s) in our database, spanning from 6/20/2013 to 6/20/2013.
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. Colep Consumer Products Portugal, S.A.'s FEI number is 3029669126.
What types of violations has Colep Consumer Products Portugal, S.A. received?
Colep Consumer Products Portugal, 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 Colep Consumer Products Portugal, S.A. come from?
All FDA import refusal data for Colep Consumer Products Portugal, 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.