OPTOPOL TECHNOLOGY S.A.
✅ Low Risk
FEI: 3006853861 • Zawiercie, Slaskie • POLAND
FEI Number
3006853861
Location
Zawiercie, Slaskie
Country
POLANDAddress
Ul. Zabia 42, , Zawiercie, Slaskie, Poland
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is OPTOPOL TECHNOLOGY S.A.'s FDA import refusal history?
OPTOPOL TECHNOLOGY S.A. (FEI: 3006853861) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2011 to 10/25/2011.
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. OPTOPOL TECHNOLOGY S.A.'s FEI number is 3006853861.
What types of violations has OPTOPOL TECHNOLOGY S.A. received?
OPTOPOL TECHNOLOGY S.A. 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 OPTOPOL TECHNOLOGY S.A. come from?
All FDA import refusal data for OPTOPOL TECHNOLOGY S.A. 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.