Nicholas Piramal India Limited
⚠️ Moderate Risk
FEI: 3004333563 • Thane West, Maharashtra • INDIA
FEI Number
3004333563
Location
Thane West, Maharashtra
Country
INDIAAddress
Mumbai Agra Road, Balkum, Thane West, Maharashtra, 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).
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 Nicholas Piramal India Limited's FDA import refusal history?
Nicholas Piramal India Limited (FEI: 3004333563) has 2 FDA import refusal record(s) in our database, spanning from 3/27/2007 to 7/2/2009.
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. Nicholas Piramal India Limited's FEI number is 3004333563.
What types of violations has Nicholas Piramal India Limited received?
Nicholas Piramal India Limited 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 Nicholas Piramal India Limited come from?
All FDA import refusal data for Nicholas Piramal India Limited 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.