Granules India Limited
⚠️ Moderate Risk
FEI: 3003616352 • Hyderabad, Telangana • INDIA
FEI Number
3003616352
Location
Hyderabad, Telangana
Country
INDIAAddress
Road No 2, 2 293/A/A/2 Banjara Hills Road, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2008 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/12/2008 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/19/2006 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/13/2006 | 64BAS99DIURETIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/13/2006 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Granules India Limited's FDA import refusal history?
Granules India Limited (FEI: 3003616352) has 5 FDA import refusal record(s) in our database, spanning from 6/13/2006 to 9/4/2008.
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 3003616352.
What types of violations has Granules India Limited received?
Granules India 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 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.