AYURVEDANT PVT LTD, NEW DELHI
⚠️ Moderate Risk
FEI: 3012645181 • New Delhi, Delhi • INDIA
FEI Number
3012645181
Location
New Delhi, Delhi
Country
INDIAAddress
31, Link Road, 2nd Floor, Lajpat Nagar 3, Lajpat Nagar (SouthDelhi), South Delhi, New Delhi, Delhi, 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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/21/2012 | 66VIE99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AYURVEDANT PVT LTD, NEW DELHI's FDA import refusal history?
AYURVEDANT PVT LTD, NEW DELHI (FEI: 3012645181) has 4 FDA import refusal record(s) in our database, spanning from 5/21/2012 to 6/14/2016.
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. AYURVEDANT PVT LTD, NEW DELHI's FEI number is 3012645181.
What types of violations has AYURVEDANT PVT LTD, NEW DELHI received?
AYURVEDANT PVT LTD, NEW DELHI 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 AYURVEDANT PVT LTD, NEW DELHI come from?
All FDA import refusal data for AYURVEDANT PVT LTD, NEW DELHI 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.