Wicks Pharmaceuticals Pvt Ltd
⚠️ High Risk
FEI: 3004409883 • Hyderabad, Telangana • INDIA
FEI Number
3004409883
Location
Hyderabad, Telangana
Country
INDIAAddress
52, , 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
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 |
|---|---|---|---|
| 4/13/2004 | 62CCB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2004 | 60SCB99ANTACID, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65PCP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 61JCP12LOVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 62OCP29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 62KCP10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65PCP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 62TCP02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 62OCP24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65DCP06OXYTOCIN (INJECTION) (OXYTOCIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65PCP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65PCP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 65PCP57CARISOPRODOL (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wicks Pharmaceuticals Pvt Ltd's FDA import refusal history?
Wicks Pharmaceuticals Pvt Ltd (FEI: 3004409883) has 14 FDA import refusal record(s) in our database, spanning from 2/24/2004 to 4/13/2004.
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. Wicks Pharmaceuticals Pvt Ltd's FEI number is 3004409883.
What types of violations has Wicks Pharmaceuticals Pvt Ltd received?
Wicks Pharmaceuticals 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 Wicks Pharmaceuticals Pvt Ltd come from?
All FDA import refusal data for Wicks Pharmaceuticals 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.