La Sirena-Mella
⚠️ High Risk
FEI: 3003319087 • Santo Domingo Rep Dominicana • DOMINICAN REPUBLIC
FEI Number
3003319087
Location
Santo Domingo Rep Dominicana
Country
DOMINICAN REPUBLICAddress
Ave Mella, , Santo Domingo Rep Dominicana, , Dominican Republic
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).
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).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2004 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 198COLOR LBLG | San Juan District Office (SJN-DO) |
| 5/25/2004 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 5/25/2004 | 53ED04PERMANENT WAVES (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 5/25/2004 | 53ED03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 5/25/2004 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | San Juan District Office (SJN-DO) | |
| 5/25/2004 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | San Juan District Office (SJN-DO) | |
| 5/25/2004 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 5/25/2004 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is La Sirena-Mella's FDA import refusal history?
La Sirena-Mella (FEI: 3003319087) has 8 FDA import refusal record(s) in our database, spanning from 5/25/2004 to 5/25/2004.
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. La Sirena-Mella's FEI number is 3003319087.
What types of violations has La Sirena-Mella received?
La Sirena-Mella has been cited for 5 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 La Sirena-Mella come from?
All FDA import refusal data for La Sirena-Mella 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.