GETWELL PHARMACEUTICAL PVT LTD
⚠️ Moderate Risk
FEI: 3017792680 • Gurugram, Haryana • INDIA
FEI Number
3017792680
Location
Gurugram, Haryana
Country
INDIAAddress
474 Delhi Gurgaon Road, , Gurugram, Haryana, 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
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 |
|---|---|---|---|
| 6/3/2025 | 62ICY23FLUOROURACIL (ANTI-NEOPLASTIC) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 6/3/2025 | 62ICY15CYCLOPHOSPHAMIDE (ANTI-NEOPLASTIC) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 6/3/2025 | 61PCK35INSULIN HUMAN/INSULIN SUSP ISOPHANE HUMA (ANTI-DIABETIC) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is GETWELL PHARMACEUTICAL PVT LTD's FDA import refusal history?
GETWELL PHARMACEUTICAL PVT LTD (FEI: 3017792680) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 6/3/2025.
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. GETWELL PHARMACEUTICAL PVT LTD's FEI number is 3017792680.
What types of violations has GETWELL PHARMACEUTICAL PVT LTD received?
GETWELL PHARMACEUTICAL PVT LTD 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 GETWELL PHARMACEUTICAL PVT LTD come from?
All FDA import refusal data for GETWELL PHARMACEUTICAL PVT 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.