Gland Pharma Limited
⚠️ High Risk
FEI: 3002647489 • Hyderabad, Telangana • INDIA
FEI Number
3002647489
Location
Hyderabad, Telangana
Country
INDIAAddress
Survey No. 143-148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District, Hyderabad, Telangana, 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
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.
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/8/2024 | 61LCP08HEPARIN SODIUM (ANTI-COAGULANT) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 12/3/2015 | 61LCK21ANTI-COAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Florida District Office (FLA-DO) | |
| 9/6/2011 | 66KCP04DOXERCALCIFEROL (THYROID INHIBITOR) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 9/6/2011 | 65RCP20SODIUM LACTATE (REPLENISHER) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 9/6/2011 | 65RCP20SODIUM LACTATE (REPLENISHER) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 9/6/2011 | 63FCP15DEXRAZOXANE (CARDIOTONIC) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/23/2011 | 63FCP15DEXRAZOXANE (CARDIOTONIC) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 2/3/2011 | 64RCP09COSYNTROPIN (HORMONE) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 6/2/2010 | 64BCP24FUROSEMIDE (DIURETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gland Pharma Limited's FDA import refusal history?
Gland Pharma Limited (FEI: 3002647489) has 9 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 7/8/2024.
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. Gland Pharma Limited's FEI number is 3002647489.
What types of violations has Gland Pharma Limited received?
Gland Pharma Limited has been cited for 4 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 Gland Pharma Limited come from?
All FDA import refusal data for Gland Pharma 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.