ZYDUS CADILLAZYDUS HEALTHCARE LT
⚠️ High Risk
FEI: 3016958851 • Kamaray Bhasmay • INDIA
FEI Number
3016958851
Location
Kamaray Bhasmay
Country
INDIAAddress
967 965 970 Dugan Circl, , Kamaray Bhasmay, , 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
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).
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.
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
Frequently Asked Questions
What is ZYDUS CADILLAZYDUS HEALTHCARE LT's FDA import refusal history?
ZYDUS CADILLAZYDUS HEALTHCARE LT (FEI: 3016958851) has 2 FDA import refusal record(s) in our database, spanning from 9/4/2025 to 11/28/2025.
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. ZYDUS CADILLAZYDUS HEALTHCARE LT's FEI number is 3016958851.
What types of violations has ZYDUS CADILLAZYDUS HEALTHCARE LT received?
ZYDUS CADILLAZYDUS HEALTHCARE LT 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 ZYDUS CADILLAZYDUS HEALTHCARE LT come from?
All FDA import refusal data for ZYDUS CADILLAZYDUS HEALTHCARE LT 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.