Apicore Pharmaceuticals Private Ltd
⚠️ Moderate Risk
FEI: 3006767695 • Vadodara, Gujarat • INDIA
FEI Number
3006767695
Location
Vadodara, Gujarat
Country
INDIAAddress
Block No 252-253, Village-Dhobikuva, Opposite Jain Irrigation, 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).
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).
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 |
|---|---|---|---|
| 11/25/2020 | 62BCS04COLESTIPOL HCL (ANTI-HYPERLIPIDEMIC) | Division of Southeast Imports (DSEI) | |
| 3/29/2018 | 60GIY01DISULFIRAM (ALCOHOL DETERRENT) | Division of Southeast Imports (DSEI) | |
| 8/12/2016 | 56ACS99PENICILLIN NATURAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/19/2016 | 64TCR01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/29/2015 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/12/2015 | 66VAZ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/10/2014 | 62GCS20DIFLUNISAL (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Apicore Pharmaceuticals Private Ltd's FDA import refusal history?
Apicore Pharmaceuticals Private Ltd (FEI: 3006767695) has 7 FDA import refusal record(s) in our database, spanning from 1/10/2014 to 11/25/2020.
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. Apicore Pharmaceuticals Private Ltd's FEI number is 3006767695.
What types of violations has Apicore Pharmaceuticals Private Ltd received?
Apicore Pharmaceuticals Private 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 Apicore Pharmaceuticals Private Ltd come from?
All FDA import refusal data for Apicore Pharmaceuticals Private 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.