One World Pharma Pvt. Ltd.
⚠️ High Risk
FEI: 3004467232 • Mumbai, Maharashtra • INDIA
FEI
FEI Number
3004467232
📍
Location
Mumbai, Maharashtra
🇮🇳
Country
INDIA🏢
Address
2nd Fl, 201/202/203 Makwana Road, Mumbai, Maharashtra, India
High Risk
FDA Import Risk Assessment
59.1
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
77
Total Refusals
3
Unique Violations
1/12/2006
Latest Refusal
3/30/2004
Earliest Refusal
Score Breakdown
Violation Severity
70.1×40%
Refusal Volume
70.1×30%
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
7577×
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).
11876×
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).
1675×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2006 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/11/2004 | 61TDA12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61QDA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62LDA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA09GLIPIZIDE (ANTI-DIABETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 63ADB02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 64GDB16CONJUGATED ESTROGENS (ESTROGEN) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA99ANTI-DIABETIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA26METFORMIN (ANTI-DIABETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61EDQ11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61EDQ09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61EDQ99ANTI-ASTHMATIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 64BDA25HYDROCHLOROTHIAZIDE (DIURETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 64BDA24FUROSEMIDE (DIURETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62KDE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60SDA99ANTACID, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62TDF06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62TDF02LANSOPRAZOLE (ANTI-SECRETORY) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62JDB13DONEPEZIL HCL (ANTI-PARKINSONIAN) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA99ANTI-DEPRESSANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 66NDB03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDF69GABAPENTIN (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62GDB99ANTI-INFLAMMATORY N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60LDF83CELECOXIB (ANALGESIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60LDA99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA99ANTI-DIABETIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61JDB99ANTI-CHOLESTEREMIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60XDA17ATENOLOL (ANTI-ADRENERGIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61JDB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61QDA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62JDA18SELEGILINE HYDROCHLORIDE (ANTI-PARKINSONIAN) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA09GLIPIZIDE (ANTI-DIABETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 63ADB02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61PDA99ANTI-DIABETIC N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60CDK54BRIMONIDINE TARTRATE (ADRENERGIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61EDQ04BUDESONIDE (ANTI-ASTHMATIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61EDQ99ANTI-ASTHMATIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60SDA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60SDA99ANTACID, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62TDF02LANSOPRAZOLE (ANTI-SECRETORY) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 66NDB04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA77PAROXETINE HCL (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDF69GABAPENTIN (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61NDF29FLUOXETINE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62GDB99ANTI-INFLAMMATORY N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 60LDF83CELECOXIB (ANALGESIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 66SDA27NIFEDIPINE (VASODILATOR) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62CDB99ANTI-HYPERTENSIVE N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 64BDA24FUROSEMIDE (DIURETIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62OCA20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61JDB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | San Francisco District Office (SAN-DO) | |
| 5/11/2004 | 61UDA05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | San Francisco District Office (SAN-DO) | |
| 3/30/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is One World Pharma Pvt. Ltd.'s FDA import refusal history?
One World Pharma Pvt. Ltd. (FEI: 3004467232) has 77 FDA import refusal record(s) in our database, spanning from 3/30/2004 to 1/12/2006.
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. One World Pharma Pvt. Ltd.'s FEI number is 3004467232.
What types of violations has One World Pharma Pvt. Ltd. received?
One World Pharma 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 One World Pharma Pvt. Ltd. come from?
All FDA import refusal data for One World Pharma 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.