Ava Cholayil Health Care Pvt Ltd
⚠️ Moderate Risk
FEI: 3009219354 • Tamilnadu • INDIA
FEI Number
3009219354
Location
Tamilnadu
Country
INDIAAddress
61-62, Sidco Industrial Estate, , Chennai-600 124, Tamilnadu, , 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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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
Frequently Asked Questions
What is Ava Cholayil Health Care Pvt Ltd's FDA import refusal history?
Ava Cholayil Health Care Pvt Ltd (FEI: 3009219354) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2011 to 10/25/2011.
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. Ava Cholayil Health Care Pvt Ltd's FEI number is 3009219354.
What types of violations has Ava Cholayil Health Care Pvt Ltd received?
Ava Cholayil Health Care Pvt Ltd 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 Ava Cholayil Health Care Pvt Ltd come from?
All FDA import refusal data for Ava Cholayil Health Care 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.