OM SAI PHARMA PACK
⚠️ High Risk
FEI: 3015505467 • Haridwar • INDIA
FEI Number
3015505467
Location
Haridwar
Country
INDIAAddress
Plot No 38, 39, Sidcul, , Haridwar, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 OM SAI PHARMA PACK's FDA import refusal history?
OM SAI PHARMA PACK (FEI: 3015505467) has 2 FDA import refusal record(s) in our database, spanning from 12/17/2024 to 4/8/2025.
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. OM SAI PHARMA PACK's FEI number is 3015505467.
What types of violations has OM SAI PHARMA PACK received?
OM SAI PHARMA PACK 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 OM SAI PHARMA PACK come from?
All FDA import refusal data for OM SAI PHARMA PACK 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.