Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)
⚠️ Moderate Risk
FEI: 3004810446 • Vapi, Gujarat • INDIA
FEI Number
3004810446
Location
Vapi, Gujarat
Country
INDIAAddress
Plot No 322/4, 40 Shed Area; Gidc, Vapi, 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
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.
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 |
|---|---|---|---|
| 5/21/2015 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | Cincinnati District Office (CIN-DO) | |
| 6/9/2014 | 62GIR90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 7/9/2002 | 62LCS40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)'s FDA import refusal history?
Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) (FEI: 3004810446) has 3 FDA import refusal record(s) in our database, spanning from 7/9/2002 to 5/21/2015.
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. Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)'s FEI number is 3004810446.
What types of violations has Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) received?
Amoli Organics (A Division of Umedica Laboratories 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 Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) come from?
All FDA import refusal data for Amoli Organics (A Division of Umedica Laboratories 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.