Synthesia, a.s.
⚠️ Moderate Risk
FEI: 3002675552 • Pardubice 2 • CZECH REPUBLIC
FEI Number
3002675552
Location
Pardubice 2
Country
CZECH REPUBLICAddress
Semtin 103, , Pardubice 2, , Czech Republic
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2016 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | New Orleans District Office (NOL-DO) |
| 5/3/2005 | 60QAS56BENZOCAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 60QAS56BENZOCAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 60QAS56BENZOCAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/7/2002 | 60QDS67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/7/2002 | 60QBS56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Synthesia, a.s.'s FDA import refusal history?
Synthesia, a.s. (FEI: 3002675552) has 6 FDA import refusal record(s) in our database, spanning from 11/7/2002 to 5/18/2016.
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. Synthesia, a.s.'s FEI number is 3002675552.
What types of violations has Synthesia, a.s. received?
Synthesia, a.s. 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 Synthesia, a.s. come from?
All FDA import refusal data for Synthesia, a.s. 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.