Schering Plough S.A.
⚠️ High Risk
FEI: 3000998582 • Rio De Janerio • BRAZIL
FEI Number
3000998582
Location
Rio De Janerio
Country
BRAZILAddress
Unknown Street, , Rio De Janerio, , Brazil
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 472NO ENGLISH | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 472NO ENGLISH | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 56YYA99ANTIBIOTIC N.E.C. | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 61GCA84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 60WAA01ALBENDAZOLE (ANTHELMINTIC) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 61NAA99ANTI-DEPRESSANT N.E.C. | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 65VCA15DIAZEPAM (SEDATIVE) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 65VCA15DIAZEPAM (SEDATIVE) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 56DDJ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 56KYL70RIFAMPIN | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 342PERSONALRX | Atlanta District Office (ATL-DO) |
| 4/6/2007 | 64GDB28ESTROGENS CONJUGATED (ESTROGEN) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Schering Plough S.A.'s FDA import refusal history?
Schering Plough S.A. (FEI: 3000998582) has 18 FDA import refusal record(s) in our database, spanning from 4/6/2007 to 4/6/2007.
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.A.'s FEI number is 3000998582.
What types of violations has Schering Plough S.A. received?
Schering Plough S.A. has been cited for 3 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 S.A. come from?
All FDA import refusal data for Schering Plough S.A. 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.