SERDIA PHARMACEUTICALS INDIA
⚠️ Moderate Risk
FEI: 3015953974 • Mumbai • INDIA
FEI Number
3015953974
Location
Mumbai
Country
INDIAAddress
Crescenzo 1703, Plot No, , Mumbai, , 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 SERDIA PHARMACEUTICALS INDIA's FDA import refusal history?
SERDIA PHARMACEUTICALS INDIA (FEI: 3015953974) has 2 FDA import refusal record(s) in our database, spanning from 2/5/2021 to 12/6/2021.
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. SERDIA PHARMACEUTICALS INDIA's FEI number is 3015953974.
What types of violations has SERDIA PHARMACEUTICALS INDIA received?
SERDIA PHARMACEUTICALS INDIA 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 SERDIA PHARMACEUTICALS INDIA come from?
All FDA import refusal data for SERDIA PHARMACEUTICALS INDIA 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.