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Avara Aiken Pharmaceutical Services Inc.

⚠️ Moderate Risk

FEI: 1046838 • Aiken, SC • UNITED STATES

FEI

FEI Number

1046838

📍

Location

Aiken, SC

🇺🇸
🏢

Address

65 Windham Blvd, , Aiken, SC, United States

Moderate Risk

FDA Import Risk Assessment

30.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/25/2013
Latest Refusal
5/21/2002
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.8×10%
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

1182×

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).

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
7/25/2013
66BAY44NICOTINE DELIVERY SYSTEM
118NOT LISTED
Atlanta District Office (ATL-DO)
5/21/2002
60SAA07PRECIPITATED CALCIUM CARBONATE (ANTACID)
118NOT LISTED
186INSANITARY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Avara Aiken Pharmaceutical Services Inc.'s FDA import refusal history?

Avara Aiken Pharmaceutical Services Inc. (FEI: 1046838) has 2 FDA import refusal record(s) in our database, spanning from 5/21/2002 to 7/25/2013.

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. Avara Aiken Pharmaceutical Services Inc.'s FEI number is 1046838.

What types of violations has Avara Aiken Pharmaceutical Services Inc. received?

Avara Aiken Pharmaceutical Services 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 Avara Aiken Pharmaceutical Services Inc. come from?

All FDA import refusal data for Avara Aiken Pharmaceutical Services 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.