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Remedylink Inc

⚠️ Moderate Risk

FEI: 3009230703 • Makawao, HI • UNITED STATES

FEI

FEI Number

3009230703

📍

Location

Makawao, HI

🇺🇸
🏢

Address

372 Hoopalua Dr, , Makawao, HI, United States

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/25/2011
Latest Refusal
11/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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
11/25/2011
55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/25/2011
55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Remedylink Inc's FDA import refusal history?

Remedylink Inc (FEI: 3009230703) has 2 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 11/25/2011.

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. Remedylink Inc's FEI number is 3009230703.

What types of violations has Remedylink Inc received?

Remedylink 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 Remedylink Inc come from?

All FDA import refusal data for Remedylink 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.