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Schering Plough Prod Llc Las Pie

⚠️ Moderate Risk

FEI: 3002778664 • Las Piedras, PR • UNITED STATES

FEI

FEI Number

3002778664

📍

Location

Las Piedras, PR

🇺🇸
🏢

Address

Call Box K 1779, , Las Piedras, PR, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/22/2010
Latest Refusal
9/22/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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
9/22/2010
61JCA15EZETIMIBE
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Schering Plough Prod Llc Las Pie's FDA import refusal history?

Schering Plough Prod Llc Las Pie (FEI: 3002778664) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2010 to 9/22/2010.

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. Schering Plough Prod Llc Las Pie's FEI number is 3002778664.

What types of violations has Schering Plough Prod Llc Las Pie received?

Schering Plough Prod Llc Las Pie 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 Prod Llc Las Pie come from?

All FDA import refusal data for Schering Plough Prod Llc Las Pie 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.