Ajanta Medicals PVT.LTD.
⚠️ High Risk
FEI: 3007218048 • Ponda, Goa • 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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2025 | 54FNL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/30/2025 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/2/2024 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/28/2024 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 9/27/2024 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/7/2019 | 54YBL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/14/2017 | 64HPL99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/14/2017 | 64HPL99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/16/2016 | 64HBL99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/21/2015 | 64HBK99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/17/2014 | 64HBL99EXPECTORANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/28/2013 | 54FGN99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/26/2012 | 41YGT99DIETARY CONVENTIONAL FOODS, N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
| 1/15/2009 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ajanta Medicals PVT.LTD.'s FDA import refusal history?
Ajanta Medicals PVT.LTD. (FEI: 3007218048) has 14 FDA import refusal record(s) in our database, spanning from 1/15/2009 to 2/12/2025.
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. Ajanta Medicals PVT.LTD.'s FEI number is 3007218048.
What types of violations has Ajanta Medicals PVT.LTD. received?
Ajanta Medicals PVT.LTD. has been cited for 10 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 Ajanta Medicals PVT.LTD. come from?
All FDA import refusal data for Ajanta Medicals 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.