APPLE THERAPEUTICS PRIVATE LIMITED
⚠️ High Risk
FEI: 3021053971 • New Delhi, Delhi • INDIA
FEI Number
3021053971
Location
New Delhi, Delhi
Country
INDIAAddress
FIFTH FLOOR, 506, 507 and 507A, HEMKUNT TOWER, 98, NEHRU PLACE, New Delhi, Delhi, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is APPLE THERAPEUTICS PRIVATE LIMITED's FDA import refusal history?
APPLE THERAPEUTICS PRIVATE LIMITED (FEI: 3021053971) has 1 FDA import refusal record(s) in our database, spanning from 1/24/2025 to 1/24/2025.
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. APPLE THERAPEUTICS PRIVATE LIMITED's FEI number is 3021053971.
What types of violations has APPLE THERAPEUTICS PRIVATE LIMITED received?
APPLE THERAPEUTICS PRIVATE LIMITED has been cited for 1 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 APPLE THERAPEUTICS PRIVATE LIMITED come from?
All FDA import refusal data for APPLE THERAPEUTICS 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.