Biocon Limited
⚠️ High Risk
FEI: 1000172912 • Bangalore, Karnataka • INDIA
FEI Number
1000172912
Location
Bangalore, Karnataka
Country
INDIAAddress
20th K M Hosur Road, Electronic City, , Bangalore, Karnataka, India
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/30/2025 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2019 | 64TAA12SIROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2006 | 60RCS18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/6/2005 | 61JIS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/8/2004 | 61PIR99ANTI-DIABETIC N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Biocon Limited's FDA import refusal history?
Biocon Limited (FEI: 1000172912) has 5 FDA import refusal record(s) in our database, spanning from 4/8/2004 to 6/30/2025.
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. Biocon Limited's FEI number is 1000172912.
What types of violations has Biocon Limited received?
Biocon Limited 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 Biocon Limited come from?
All FDA import refusal data for Biocon 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.