Biocon Biologics Limited
⚠️ Moderate Risk
FEI: 3003981475 • Bengaluru, Karnataka • INDIA
FEI Number
3003981475
Location
Bengaluru, Karnataka
Country
INDIAAddress
Block No, B1,B2, B3, B5, Q13 Of Q1 And W20 & Unit S18,1st Floor, Block B4, Sez, Plot No.2,3,4&5, Phase Iv, Bommasandra-Jigani Link Road, Bengaluru, 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).
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).
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.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/17/2021 | 61YIA03ETANERCEPT | 179AGR RX | Division of Northeast Imports (DNEI) |
| 1/5/2016 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2014 | 61SCR04PIMECROLIMUS | Division of Southeast Imports (DSEI) | |
| 10/22/2009 | 61KCR04ATROPINE OXIDE HCL (ANTI-CHOLINERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/18/2007 | 61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2006 | 61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/5/2006 | 61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/16/2005 | 61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 7/23/2004 | 61JCS14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 12/9/2003 | 62GBZ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Biocon Biologics Limited's FDA import refusal history?
Biocon Biologics Limited (FEI: 3003981475) has 10 FDA import refusal record(s) in our database, spanning from 12/9/2003 to 9/17/2021.
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. Biocon Biologics Limited's FEI number is 3003981475.
What types of violations has Biocon Biologics Limited received?
Biocon Biologics Limited has been cited for 5 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 Biologics Limited come from?
All FDA import refusal data for Biocon Biologics 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.