Ocean Healthcare Pvt Ltd
⚠️ Moderate Risk
FEI: 3015621300 • Chengalpattu District, Tamil Nadu • INDIA
FEI Number
3015621300
Location
Chengalpattu District, Tamil Nadu
Country
INDIAAddress
Survey No. 86-1-6, Orthur Village, Thiruporur Taluk, Chengalpattu District, Tamil Nadu, 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).
Refusal History
Frequently Asked Questions
What is Ocean Healthcare Pvt Ltd's FDA import refusal history?
Ocean Healthcare Pvt Ltd (FEI: 3015621300) has 2 FDA import refusal record(s) in our database, spanning from 7/12/2022 to 7/12/2022.
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. Ocean Healthcare Pvt Ltd's FEI number is 3015621300.
What types of violations has Ocean Healthcare Pvt Ltd received?
Ocean Healthcare Pvt Ltd has been cited for 1 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 Ocean Healthcare Pvt Ltd come from?
All FDA import refusal data for Ocean Healthcare 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.