Ayushakti Ayurved Pvt Ltd
⚠️ Moderate Risk
FEI: 3003045454 • Mumbai, Maharashtra • INDIA
FEI Number
3003045454
Location
Mumbai, Maharashtra
Country
INDIAAddress
A5 Haridas Nagar Road, , Mumbai, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2008 | 66YCL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/27/2003 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/27/2003 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ayushakti Ayurved Pvt Ltd's FDA import refusal history?
Ayushakti Ayurved Pvt Ltd (FEI: 3003045454) has 3 FDA import refusal record(s) in our database, spanning from 2/27/2003 to 9/2/2008.
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. Ayushakti Ayurved Pvt Ltd's FEI number is 3003045454.
What types of violations has Ayushakti Ayurved Pvt Ltd received?
Ayushakti Ayurved Pvt Ltd has been cited for 3 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 Ayushakti Ayurved Pvt Ltd come from?
All FDA import refusal data for Ayushakti Ayurved 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.