Zydus Healthcare Ltd
⚠️ High Risk
FEI: 3013654969 • Rangpo, East Sikkim • INDIA
FEI Number
3013654969
Location
Rangpo, East Sikkim
Country
INDIAAddress
NH No 10 Majhitar, , Rangpo, East Sikkim, 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 |
|---|---|---|---|
| 1/2/2026 | 63BCY30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2024 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2024 | 65JCA25NORETHINDRONE ACETATE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2021 | 63BDA99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 56HCA45MITOMYCIN (ANTITUMOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 61HCY43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zydus Healthcare Ltd's FDA import refusal history?
Zydus Healthcare Ltd (FEI: 3013654969) has 8 FDA import refusal record(s) in our database, spanning from 12/11/2018 to 1/2/2026.
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. Zydus Healthcare Ltd's FEI number is 3013654969.
What types of violations has Zydus Healthcare Ltd received?
Zydus Healthcare Ltd 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 Zydus Healthcare Ltd come from?
All FDA import refusal data for Zydus Healthcare 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.