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Unither Manufacturing LLC.

⚠️ Moderate Risk

FEI: 1314625 • Rochester, NY • UNITED STATES

FEI

FEI Number

1314625

📍

Location

Rochester, NY

🇺🇸
🏢

Address

755 Jefferson Rd, , Rochester, NY, United States

Moderate Risk

FDA Import Risk Assessment

47.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/4/2025
Latest Refusal
11/4/2025
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
96.3×20%
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

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
11/4/2025
58SCP06CERTOLIZUMAB PEGOL
179AGR RX
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Unither Manufacturing LLC.'s FDA import refusal history?

Unither Manufacturing LLC. (FEI: 1314625) has 1 FDA import refusal record(s) in our database, spanning from 11/4/2025 to 11/4/2025.

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. Unither Manufacturing LLC.'s FEI number is 1314625.

What types of violations has Unither Manufacturing LLC. received?

Unither Manufacturing LLC. 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 Unither Manufacturing LLC. come from?

All FDA import refusal data for Unither Manufacturing LLC. 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.