Schering Plough Sa Exp
⚠️ High Risk
FEI: 3000955768 • Bogota • COLOMBIA
FEI Number
3000955768
Location
Bogota
Country
COLOMBIAAddress
Carrera 68 # 19-20, , Bogota, , Colombia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2005 | 64LDY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 61WCP45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 61BDC02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Schering Plough Sa Exp's FDA import refusal history?
Schering Plough Sa Exp (FEI: 3000955768) has 8 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 10/25/2005.
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 Sa Exp's FEI number is 3000955768.
What types of violations has Schering Plough Sa Exp received?
Schering Plough Sa Exp 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 Sa Exp come from?
All FDA import refusal data for Schering Plough Sa Exp 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.