Botanicus, Spol S.R.O.
⚠️ High Risk
FEI: 3010079337 • Nad Labem • CZECH REPUBLIC
FEI Number
3010079337
Location
Nad Labem
Country
CZECH REPUBLICAddress
Ostra 8 289 22 Lysa, , Nad Labem, , Czech 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
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).
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 11/20/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 4/24/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/24/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/24/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/24/2014 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/21/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 4/17/2013 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/17/2013 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/17/2013 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/17/2013 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/17/2013 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Botanicus, Spol S.R.O.'s FDA import refusal history?
Botanicus, Spol S.R.O. (FEI: 3010079337) has 21 FDA import refusal record(s) in our database, spanning from 4/17/2013 to 11/20/2014.
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. Botanicus, Spol S.R.O.'s FEI number is 3010079337.
What types of violations has Botanicus, Spol S.R.O. received?
Botanicus, Spol S.R.O. 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 Botanicus, Spol S.R.O. come from?
All FDA import refusal data for Botanicus, Spol S.R.O. 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.