Comercial Farmaceutica
⚠️ Moderate Risk
FEI: 3005820605 • San Jose • COSTA RICA
FEI Number
3005820605
Location
San Jose
Country
COSTA RICAAddress
El Aquila de Oro S.A., San Isidro de Coronado, San Jose, , Costa Rica
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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 |
|---|---|---|---|
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 11/14/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Comercial Farmaceutica's FDA import refusal history?
Comercial Farmaceutica (FEI: 3005820605) has 8 FDA import refusal record(s) in our database, spanning from 11/14/2006 to 11/14/2006.
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. Comercial Farmaceutica's FEI number is 3005820605.
What types of violations has Comercial Farmaceutica received?
Comercial Farmaceutica 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 Comercial Farmaceutica come from?
All FDA import refusal data for Comercial Farmaceutica 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.