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Sandoz Incorporated

⚠️ Moderate Risk

FEI: 1717759 • East Hanover, NJ • UNITED STATES

FEI

FEI Number

1717759

📍

Location

East Hanover, NJ

🇺🇸
🏢

Address

1 Health Plz, , East Hanover, NJ, United States

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
11/20/2012
Latest Refusal
2/27/2007
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
12.2×10%
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

1797×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
11/20/2012
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
Florida District Office (FLA-DO)
9/14/2011
66MCY95TEMAZEPAM (TRANQUILIZER)
179AGR RX
Division of Southeast Imports (DSEI)
8/21/2009
56BDL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
179AGR RX
Southwest Import District Office (SWI-DO)
12/18/2008
56AAA99PENICILLIN NATURAL, N.E.C.
179AGR RX
New York District Office (NYK-DO)
2/27/2007
64UDB06FINASTERIDE (INHIBITOR (DECARBOXYLASE))
179AGR RX
Cincinnati District Office (CIN-DO)
2/27/2007
60SDB24RANITIDINE BISMUTH CITRATE (ANTACID)
179AGR RX
Cincinnati District Office (CIN-DO)
2/27/2007
60XDB17ATENOLOL (ANTI-ADRENERGIC)
179AGR RX
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sandoz Incorporated's FDA import refusal history?

Sandoz Incorporated (FEI: 1717759) has 7 FDA import refusal record(s) in our database, spanning from 2/27/2007 to 11/20/2012.

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. Sandoz Incorporated's FEI number is 1717759.

What types of violations has Sandoz Incorporated received?

Sandoz Incorporated 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 Sandoz Incorporated come from?

All FDA import refusal data for Sandoz Incorporated 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.