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Melinta Therapeutics, Inc.

⚠️ Moderate Risk

FEI: 3012876740 • Lincolnshire, IL • UNITED STATES

FEI

FEI Number

3012876740

📍

Location

Lincolnshire, IL

🇺🇸
🏢

Address

300 Tri-State International, , Lincolnshire, IL, United States

Moderate Risk

FDA Import Risk Assessment

33.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/14/2022
Latest Refusal
2/14/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
7.8×20%
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

1181×

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).

751×

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
2/14/2022
61GCY80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Melinta Therapeutics, Inc.'s FDA import refusal history?

Melinta Therapeutics, Inc. (FEI: 3012876740) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2022 to 2/14/2022.

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. Melinta Therapeutics, Inc.'s FEI number is 3012876740.

What types of violations has Melinta Therapeutics, Inc. received?

Melinta Therapeutics, Inc. 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 Melinta Therapeutics, Inc. come from?

All FDA import refusal data for Melinta Therapeutics, 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.