Wicks Pharmaceuticals Pvt Ltd
🚨 Critical Risk
FEI: 3004407687 • Bangalore • INDIA
Critical Risk
FDA Import Risk Assessment
75.9
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
580
Total Refusals
3
Unique Violations
2/27/2004
Latest Refusal
2/22/2004
Earliest Refusal
Score Breakdown
Violation Severity
89.8×40%
Refusal Volume
100.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
75576×
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).
1793×
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
271×
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2004 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 62KCC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 62OCB43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 61NDB76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 60LCB88SUMATRIPTAN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 61NCB69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2004 | 64GCA28ESTROGENS CONJUGATED (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2004 | 61ECB06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2004 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2004 | 60LIB69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2004 | 65PQA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63ACB02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCB99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63BCL25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62ODB15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61JCB13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61ECQ11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCB66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61PCB09GLIPIZIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62KCB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63ACC02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64BCC25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60SCC27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62OCB12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60XCC02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCB69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63ACC02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66NCB02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62TCF02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LIB69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64BCC25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62TCC06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62TCC06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LIB83CELECOXIB (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66MCA09BUSPIRONE HCL (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62GCC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LIB69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61HCB43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62GCF97NABUMETONE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63BCQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64BCC24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62OCB15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62KCB99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61HCB43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61HCB43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61ECF04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LIB83CELECOXIB (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61FCB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65PCB57CARISOPRODOL (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 63ACC02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62YCB07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCE69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCE99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64BCC24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65QCB65TIZANIDINE HCL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62YCB07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62ICB31METHOTREXATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA77PAROXETINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61MCB38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 56ECE20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCB29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62SCJ02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCB88SUMATRIPTAN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61ECB06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61JCB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62JCB18SELEGILINE HYDROCHLORIDE (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62JDB09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61PCB09GLIPIZIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCB89SUMATRIPTAN SUCCINATE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 61ECB06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 64BCB24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62KCB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 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: 3004407687) has 580 FDA import refusal record(s) in our database, spanning from 2/22/2004 to 2/27/2004.
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 3004407687.
What types of violations has Wicks Pharmaceuticals Pvt Ltd received?
Wicks Pharmaceuticals Pvt 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 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.