Ayurved Sumshodhanalaya (Pune) Pvt. Ltd.
⚠️ High Risk
FEI: 3009580880 • Pune, MAHARASHTRA • INDIA
FEI Number
3009580880
Location
Pune, MAHARASHTRA
Country
INDIAAddress
10,DHAYARI, OFF SINHGAD ROAD, , Pune, MAHARASHTRA, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2024 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/16/2024 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/15/2012 | 56GCJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ayurved Sumshodhanalaya (Pune) Pvt. Ltd.'s FDA import refusal history?
Ayurved Sumshodhanalaya (Pune) Pvt. Ltd. (FEI: 3009580880) has 4 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 1/16/2024.
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. Ayurved Sumshodhanalaya (Pune) Pvt. Ltd.'s FEI number is 3009580880.
What types of violations has Ayurved Sumshodhanalaya (Pune) Pvt. Ltd. received?
Ayurved Sumshodhanalaya (Pune) Pvt. Ltd. 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 Ayurved Sumshodhanalaya (Pune) Pvt. Ltd. come from?
All FDA import refusal data for Ayurved Sumshodhanalaya (Pune) 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.