Advanced Oral Care Products Pvt., Ltd
⚠️ Moderate Risk
FEI: 3005315413 • Kundaim Industrial Estate, Goa -403 115 • INDIA
FEI Number
3005315413
Location
Kundaim Industrial Estate, Goa -403 115
Country
INDIAAddress
Plot No. 154, , Kundaim Industrial Estate, Goa -403 115, 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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is Advanced Oral Care Products Pvt., Ltd's FDA import refusal history?
Advanced Oral Care Products Pvt., Ltd (FEI: 3005315413) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2005 to 12/6/2005.
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. Advanced Oral Care Products Pvt., Ltd's FEI number is 3005315413.
What types of violations has Advanced Oral Care Products Pvt., Ltd received?
Advanced Oral Care Products 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 Advanced Oral Care Products Pvt., Ltd come from?
All FDA import refusal data for Advanced Oral Care Products 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.