GSK INDIA LTD
⚠️ Moderate Risk
FEI: 3014217641 • Gurgoan • INDIA
FEI Number
3014217641
Location
Gurgoan
Country
INDIAAddress
24-25 Floor One Horizoncenter Golf Course Road Dlf Phase 5, , Gurgoan, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/3/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2019 | 29AYY70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 6/6/2019 | 60SDY99ANTACID, N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
| 6/6/2019 | 32ACT99MALT BEVERAGES, N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GSK INDIA LTD's FDA import refusal history?
GSK INDIA LTD (FEI: 3014217641) has 4 FDA import refusal record(s) in our database, spanning from 6/6/2019 to 8/3/2020.
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. GSK INDIA LTD's FEI number is 3014217641.
What types of violations has GSK INDIA LTD received?
GSK INDIA LTD 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 GSK INDIA LTD come from?
All FDA import refusal data for GSK INDIA LTD 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.