Sundyota Numandis Probioceuticals Pvt. Ltd.
⚠️ High Risk
FEI: 3018909300 • Bavla, Gujarat • INDIA
FEI Number
3018909300
Location
Bavla, Gujarat
Country
INDIAAddress
Plot No 11 - 12, Gujarat Pharma Techno Park; Opp Zydus Pharmez, Bavla, Gujarat, 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 Sundyota Numandis Probioceuticals Pvt. Ltd.'s FDA import refusal history?
Sundyota Numandis Probioceuticals Pvt. Ltd. (FEI: 3018909300) has 2 FDA import refusal record(s) in our database, spanning from 5/5/2025 to 7/11/2025.
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. Sundyota Numandis Probioceuticals Pvt. Ltd.'s FEI number is 3018909300.
What types of violations has Sundyota Numandis Probioceuticals Pvt. Ltd. received?
Sundyota Numandis Probioceuticals 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 Sundyota Numandis Probioceuticals Pvt. Ltd. come from?
All FDA import refusal data for Sundyota Numandis Probioceuticals 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.