Strides Pharma Science Limited
⚠️ Moderate Risk
FEI: 3004554612 • Bangalore, Karnataka • INDIA
FEI Number
3004554612
Location
Bangalore, Karnataka
Country
INDIAAddress
Krs Gardens, No.36/7 Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 6/7/2021 | 64TCE08TACROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2021 | 64TCE04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2012 | 62VCB24EFAVIRENZ (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Strides Pharma Science Limited's FDA import refusal history?
Strides Pharma Science Limited (FEI: 3004554612) has 3 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 6/7/2021.
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. Strides Pharma Science Limited's FEI number is 3004554612.
What types of violations has Strides Pharma Science Limited received?
Strides Pharma Science Limited 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 Strides Pharma Science Limited come from?
All FDA import refusal data for Strides Pharma Science Limited 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.