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Graceway Pharmaceuticals Llc

⚠️ Moderate Risk

FEI: 3006155916 • Bristol, TN • UNITED STATES

FEI

FEI Number

3006155916

📍

Location

Bristol, TN

🇺🇸
🏢

Address

340 Martin Luther King Jr Blvd, Ste 500, , Bristol, TN, United States

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
6/16/2010
Latest Refusal
11/6/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

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
6/16/2010
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
6/16/2010
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
6/16/2010
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
6/16/2010
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/6/2009
62VCJ29IMIQUIMOD (ANTI-VIRAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Graceway Pharmaceuticals Llc's FDA import refusal history?

Graceway Pharmaceuticals Llc (FEI: 3006155916) has 5 FDA import refusal record(s) in our database, spanning from 11/6/2009 to 6/16/2010.

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. Graceway Pharmaceuticals Llc's FEI number is 3006155916.

What types of violations has Graceway Pharmaceuticals Llc received?

Graceway Pharmaceuticals 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 Graceway Pharmaceuticals Llc come from?

All FDA import refusal data for Graceway Pharmaceuticals 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.