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Jsc Technolg

⚠️ Moderate Risk

FEI: 3008616932 • Uman • UKRAINE

FEI

FEI Number

3008616932

📍

Location

Uman

🇺🇦

Country

UKRAINE
🏢

Address

8 Manul'S Kogo Street, , Uman, , Ukraine

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
6/28/2011
Latest Refusal
6/3/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

752×

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).

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.

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

Refusal History

DateProductViolationsDivision
6/28/2011
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
6/3/2011
66SDA28NITROGLYCERIN (TAB) (VASODILATOR)
3500RXLABEL
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Jsc Technolg's FDA import refusal history?

Jsc Technolg (FEI: 3008616932) has 2 FDA import refusal record(s) in our database, spanning from 6/3/2011 to 6/28/2011.

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. Jsc Technolg's FEI number is 3008616932.

What types of violations has Jsc Technolg received?

Jsc Technolg has been cited for 4 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 Jsc Technolg come from?

All FDA import refusal data for Jsc Technolg 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.