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Alcami Carolinas Corporation

⚠️ Moderate Risk

FEI: 1049418 • Wilmington, NC • UNITED STATES

FEI

FEI Number

1049418

📍

Location

Wilmington, NC

🇺🇸
🏢

Address

2320 Scientific Park Dr, , Wilmington, NC, United States

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/14/2019
Latest Refusal
12/12/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
3.5×10%
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

754×

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
6/14/2019
60YIE99INHIBITOR (GROWTH FACTOR) N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/7/2013
56PIB01LINEZOLID (OXAZOLIDINONE)
75UNAPPROVED
Philadelphia District Office (PHI-DO)
12/8/2009
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
12/12/2007
61XCB45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Alcami Carolinas Corporation's FDA import refusal history?

Alcami Carolinas Corporation (FEI: 1049418) has 4 FDA import refusal record(s) in our database, spanning from 12/12/2007 to 6/14/2019.

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. Alcami Carolinas Corporation's FEI number is 1049418.

What types of violations has Alcami Carolinas Corporation received?

Alcami Carolinas Corporation 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 Alcami Carolinas Corporation come from?

All FDA import refusal data for Alcami Carolinas Corporation 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.