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PRIVATE JOINT STOCK COMPANY "ZOL

⚠️ Moderate Risk

FEI: 3012950510 • Zolotonosha 19700 • UKRAINE

FEI

FEI Number

3012950510

📍

Location

Zolotonosha 19700

🇺🇦

Country

UKRAINE
🏢

Address

Komunarska Street 14, , Zolotonosha 19700, , Ukraine

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
6/5/2017
Latest Refusal
6/5/2017
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

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.

751×

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).

Refusal History

DateProductViolationsDivision
6/5/2017
66VPY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PRIVATE JOINT STOCK COMPANY "ZOL's FDA import refusal history?

PRIVATE JOINT STOCK COMPANY "ZOL (FEI: 3012950510) has 1 FDA import refusal record(s) in our database, spanning from 6/5/2017 to 6/5/2017.

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. PRIVATE JOINT STOCK COMPANY "ZOL's FEI number is 3012950510.

What types of violations has PRIVATE JOINT STOCK COMPANY "ZOL received?

PRIVATE JOINT STOCK COMPANY "ZOL 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 PRIVATE JOINT STOCK COMPANY "ZOL come from?

All FDA import refusal data for PRIVATE JOINT STOCK COMPANY "ZOL 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.