Mylan Pharmaceuticals Inc.
⚠️ High Risk
FEI: 3007886374 • San Carlos, CA • UNITED STATES
FEI
FEI Number
3007886374
📍
Location
San Carlos, CA
🇺🇸
Country
UNITED STATES🏢
Address
150 Industrial Rd, , San Carlos, CA, United States
High Risk
FDA Import Risk Assessment
66.8
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
74
Total Refusals
1
Unique Violations
12/16/2016
Latest Refusal
12/16/2016
Earliest Refusal
Score Breakdown
Violation Severity
90.0×40%
Refusal Volume
69.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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
7574×
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 |
|---|---|---|---|
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/16/2016 | 61FIR54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Mylan Pharmaceuticals Inc.'s FDA import refusal history?
Mylan Pharmaceuticals Inc. (FEI: 3007886374) has 74 FDA import refusal record(s) in our database, spanning from 12/16/2016 to 12/16/2016.
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. Mylan Pharmaceuticals Inc.'s FEI number is 3007886374.
What types of violations has Mylan Pharmaceuticals Inc. received?
Mylan Pharmaceuticals Inc. 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 Mylan Pharmaceuticals Inc. come from?
All FDA import refusal data for Mylan Pharmaceuticals Inc. 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.