NIPK Electron Co.
⚠️ Moderate Risk
FEI: 3009137634 • Saint Petersburg, Sankt-Peterburg • RUSSIA
FEI Number
3009137634
Location
Saint Petersburg, Sankt-Peterburg
Country
RUSSIAAddress
Volkhonskaye Chaussee 4b, , Saint Petersburg, Sankt-Peterburg, Russia
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
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is NIPK Electron Co.'s FDA import refusal history?
NIPK Electron Co. (FEI: 3009137634) has 2 FDA import refusal record(s) in our database, spanning from 11/22/2011 to 11/22/2011.
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. NIPK Electron Co.'s FEI number is 3009137634.
What types of violations has NIPK Electron Co. received?
NIPK Electron Co. 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 NIPK Electron Co. come from?
All FDA import refusal data for NIPK Electron Co. 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.