ImportRefusal LogoImportRefusal

Milta PKP-GIT

⚠️ Moderate Risk

FEI: 3005739661 • Moscow, Moscow g • RUSSIA

FEI

FEI Number

3005739661

📍

Location

Moscow, Moscow g

🇷🇺

Country

RUSSIA
🏢

Address

Building 7, Ul. Krasnokazarmennaya 14, Office 29; Borovaya Str. 7, Moscow, Moscow g, Russia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/24/2005
Latest Refusal
10/24/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

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

DateProductViolationsDivision
10/24/2005
89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Milta PKP-GIT's FDA import refusal history?

Milta PKP-GIT (FEI: 3005739661) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 10/24/2005.

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. Milta PKP-GIT's FEI number is 3005739661.

What types of violations has Milta PKP-GIT received?

Milta PKP-GIT has been cited for 1 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 Milta PKP-GIT come from?

All FDA import refusal data for Milta PKP-GIT 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.