Asence Pharma Private Limited
⚠️ Moderate Risk
FEI: 3005757047 • Vadodara, Gujarat • INDIA
FEI Number
3005757047
Location
Vadodara, Gujarat
Country
INDIAAddress
Dr Vikram Sarabhai Marg, , Vadodara, Gujarat, 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
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2015 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/27/2015 | 61XAA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/26/2006 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Asence Pharma Private Limited's FDA import refusal history?
Asence Pharma Private Limited (FEI: 3005757047) has 3 FDA import refusal record(s) in our database, spanning from 7/26/2006 to 9/3/2015.
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. Asence Pharma Private Limited's FEI number is 3005757047.
What types of violations has Asence Pharma Private Limited received?
Asence Pharma Private Limited has been cited for 2 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 Asence Pharma Private Limited come from?
All FDA import refusal data for Asence Pharma Private Limited 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.