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Adcock Ingram Ltd

⚠️ Moderate Risk

FEI: 3003394685 • Bryanston • SOUTH AFRICA

FEI

FEI Number

3003394685

📍

Location

Bryanston

🇿🇦
🏢

Address

Adcock Ingram Park, 17 Harrison Ave, Bryanston, , South Africa

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
4/21/2008
Latest Refusal
2/15/2005
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
15.7×10%
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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
4/21/2008
66MCY03ALPRAZOLAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/31/2006
62GAO46KETOPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/31/2006
64BDJ43UREA (DIURETIC)
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/24/2005
60LAY01ACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/15/2005
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Adcock Ingram Ltd's FDA import refusal history?

Adcock Ingram Ltd (FEI: 3003394685) has 5 FDA import refusal record(s) in our database, spanning from 2/15/2005 to 4/21/2008.

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. Adcock Ingram Ltd's FEI number is 3003394685.

What types of violations has Adcock Ingram Ltd received?

Adcock Ingram Ltd 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 Adcock Ingram Ltd come from?

All FDA import refusal data for Adcock Ingram Ltd 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.