ImportRefusal LogoImportRefusal

Avara Pharmaceutical Technologies, Inc.

⚠️ High Risk

FEI: 3004998655 • Norman, OK • UNITED STATES

FEI

FEI Number

3004998655

📍

Location

Norman, OK

🇺🇸
🏢

Address

3300 Marshall Ave, , Norman, OK, United States

High Risk

FDA Import Risk Assessment

56.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
1/15/2025
Latest Refusal
1/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
75.7×20%
Frequency
1.4×10%
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

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
1/15/2025
61KCA99ANTI-CHOLINERGIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/5/2011
65QIS99RELAXANT N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Avara Pharmaceutical Technologies, Inc.'s FDA import refusal history?

Avara Pharmaceutical Technologies, Inc. (FEI: 3004998655) has 2 FDA import refusal record(s) in our database, spanning from 1/5/2011 to 1/15/2025.

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. Avara Pharmaceutical Technologies, Inc.'s FEI number is 3004998655.

What types of violations has Avara Pharmaceutical Technologies, Inc. received?

Avara Pharmaceutical Technologies, Inc. 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 Avara Pharmaceutical Technologies, Inc. come from?

All FDA import refusal data for Avara Pharmaceutical Technologies, Inc. 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.