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Baganovo

⚠️ Moderate Risk

FEI: 3006891884 • Barnet, Hertfordshire • UNITED KINGDOM

FEI

FEI Number

3006891884

📍

Location

Barnet, Hertfordshire

🇬🇧
🏢

Address

40 Gloucester Road, , Barnet, Hertfordshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/31/2008
Latest Refusal
7/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
74.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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).

1182×

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).

Refusal History

DateProductViolationsDivision
10/31/2008
62AIZ05ZOLEDRONIC ACID
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/31/2008
62ADK05ZOLEDRONIC ACID
75UNAPPROVED
Los Angeles District Office (LOS-DO)
7/10/2008
62ACK05ZOLEDRONIC ACID
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Baganovo's FDA import refusal history?

Baganovo (FEI: 3006891884) has 3 FDA import refusal record(s) in our database, spanning from 7/10/2008 to 10/31/2008.

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. Baganovo's FEI number is 3006891884.

What types of violations has Baganovo received?

Baganovo 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 Baganovo come from?

All FDA import refusal data for Baganovo 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.