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Peter Mcgovern

⚠️ Moderate Risk

FEI: 3004512674 • Edinburgh • UNITED KINGDOM

FEI

FEI Number

3004512674

📍

Location

Edinburgh

🇬🇧
🏢

Address

1 Dram Brae Gardens, , Edinburgh, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/30/2004
Latest Refusal
7/30/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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).

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).

Refusal History

DateProductViolationsDivision
7/30/2004
65UDQ99SCLEROSING AGENT N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
7/30/2004
65UDP99SCLEROSING AGENT N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Peter Mcgovern's FDA import refusal history?

Peter Mcgovern (FEI: 3004512674) has 2 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 7/30/2004.

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. Peter Mcgovern's FEI number is 3004512674.

What types of violations has Peter Mcgovern received?

Peter Mcgovern 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 Peter Mcgovern come from?

All FDA import refusal data for Peter Mcgovern 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.