Tapaszto Optic Ltd.
⚠️ Moderate Risk
FEI: 3002296055 • Kecskemet, Bacs-kiskun • HUNGARY
FEI Number
3002296055
Location
Kecskemet, Bacs-kiskun
Country
HUNGARYAddress
Csanyi Janos Korut 8, , Kecskemet, Bacs-kiskun, Hungary
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
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Tapaszto Optic Ltd.'s FDA import refusal history?
Tapaszto Optic Ltd. (FEI: 3002296055) has 1 FDA import refusal record(s) in our database, spanning from 8/18/2007 to 8/18/2007.
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. Tapaszto Optic Ltd.'s FEI number is 3002296055.
What types of violations has Tapaszto Optic Ltd. received?
Tapaszto Optic Ltd. 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 Tapaszto Optic Ltd. come from?
All FDA import refusal data for Tapaszto Optic Ltd. 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.