ATREY PHARMACEUTICALS PRIVATE LIMITED
⚠️ High Risk
FEI: 3021630215 • Gujarat • INDIA
FEI Number
3021630215
Location
Gujarat
Country
INDIAAddress
688 Paldi Kankaj Daskroi, , 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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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 |
|---|---|---|---|
| 9/24/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 26CHT99REFINED VEGETABLE OIL, SINGLE INGREDIENT, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 26CHT99REFINED VEGETABLE OIL, SINGLE INGREDIENT, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 26CHT99REFINED VEGETABLE OIL, SINGLE INGREDIENT, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/31/2017 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/31/2017 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/31/2017 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/31/2017 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ATREY PHARMACEUTICALS PRIVATE LIMITED's FDA import refusal history?
ATREY PHARMACEUTICALS PRIVATE LIMITED (FEI: 3021630215) has 10 FDA import refusal record(s) in our database, spanning from 8/31/2017 to 9/24/2025.
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. ATREY PHARMACEUTICALS PRIVATE LIMITED's FEI number is 3021630215.
What types of violations has ATREY PHARMACEUTICALS PRIVATE LIMITED received?
ATREY PHARMACEUTICALS PRIVATE LIMITED has been cited for 4 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 ATREY PHARMACEUTICALS PRIVATE LIMITED come from?
All FDA import refusal data for ATREY PHARMACEUTICALS PRIVATE LIMITED 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.