Granules India Limited
⚠️ Moderate Risk
FEI: 3006623417 • Hyderabad, Telangana • INDIA
FEI Number
3006623417
Location
Hyderabad, Telangana
Country
INDIAAddress
2nd Floor, 3rd Block My Home Hub Madhapur, Hyderabad, Telangana, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2016 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | Division of Southeast Imports (DSEI) | |
| 12/3/2015 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/27/2013 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 11/28/2012 | 61GAA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2012 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 9/12/2012 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/31/2011 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2010 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2010 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2009 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/25/2008 | 61HDA99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/11/2008 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Granules India Limited's FDA import refusal history?
Granules India Limited (FEI: 3006623417) has 12 FDA import refusal record(s) in our database, spanning from 4/11/2008 to 6/24/2016.
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. Granules India Limited's FEI number is 3006623417.
What types of violations has Granules India Limited received?
Granules India 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 Granules India Limited come from?
All FDA import refusal data for Granules India 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.