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Schering Corporation

⚠️ High Risk

FEI: 2211539 • Lafayette, NJ • UNITED STATES

FEI

FEI Number

2211539

📍

Location

Lafayette, NJ

🇺🇸
🏢

Address

144 State Route 94, , Lafayette, NJ, United States

High Risk

FDA Import Risk Assessment

52.8
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
2
Unique Violations
8/26/2008
Latest Refusal
5/10/2002
Earliest Refusal

Score Breakdown

Violation Severity
88.4×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
30.1×10%
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

7518×

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).

1791×

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
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
8/26/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
5/2/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
5/2/2008
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
5/10/2002
61KCE68TEMOZOLOMIDE (ANTI-CHOLINERGIC)
179AGR RX
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Schering Corporation's FDA import refusal history?

Schering Corporation (FEI: 2211539) has 19 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 8/26/2008.

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. Schering Corporation's FEI number is 2211539.

What types of violations has Schering Corporation received?

Schering Corporation 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 Schering Corporation come from?

All FDA import refusal data for Schering Corporation 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.