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Schering Plough

⚠️ Moderate Risk

FEI: 1000223973 • Florida Pcia, Buenos Aires • ARGENTINA

FEI

FEI Number

1000223973

📍

Location

Florida Pcia, Buenos Aires

🇦🇷

Country

ARGENTINA
🏢

Address

Avenida San Martin 1750, , Florida Pcia, Buenos Aires, Argentina

Moderate Risk

FDA Import Risk Assessment

46.7
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
3/24/2016
Latest Refusal
9/23/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
6.7×10%
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

757×

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
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
3/24/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
12/13/2011
61XCB99ANTI-HISTAMINIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/23/2005
64GBC07ESTRADIOL (ESTROGEN)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Schering Plough's FDA import refusal history?

Schering Plough (FEI: 1000223973) has 7 FDA import refusal record(s) in our database, spanning from 9/23/2005 to 3/24/2016.

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. Schering Plough's FEI number is 1000223973.

What types of violations has Schering Plough received?

Schering Plough 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 Schering Plough come from?

All FDA import refusal data for Schering Plough 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.