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Allergan Medical

Low Risk

FEI: 3011721945 • Irvine, CA • UNITED STATES

FEI

FEI Number

3011721945

📍

Location

Irvine, CA

🇺🇸
🏢

Address

2500 Michelson Dr Ste 30, , Irvine, CA, United States

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
12/2/2019
Latest Refusal
12/2/2019
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

35001×

RXLABEL

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

4721×

NO ENGLISH

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

Refusal History

DateProductViolationsDivision
12/2/2019
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
3500RXLABEL
472NO ENGLISH
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Allergan Medical's FDA import refusal history?

Allergan Medical (FEI: 3011721945) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2019 to 12/2/2019.

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. Allergan Medical's FEI number is 3011721945.

What types of violations has Allergan Medical received?

Allergan Medical 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 Allergan Medical come from?

All FDA import refusal data for Allergan Medical 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.