Zydus Lifesciences Limited
⚠️ Moderate Risk
FEI: 3002984011 • Ahmedabad, Gujarat • INDIA
FEI Number
3002984011
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Survey No. 417, 419 and 420, Sarkhej Bavla N. H. No. 8A Village-Moraiya, , Taluka Sanand, Ahmedabad, Gujarat, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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) in that it is a device whose labeling appears to be false or misleading.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2022 | 64RCE17ANASTROZOLE (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2020 | 64MCY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2016 | 63BDA35CLENBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/12/2016 | 64MDA04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2016 | 64MCK04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/17/2016 | 64MDP04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 8/13/2014 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 223FALSE | Baltimore District Office (BLT-DO) |
| 8/13/2014 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 223FALSE | Baltimore District Office (BLT-DO) |
| 4/26/2007 | 61NIA76PAROXETINE (ANTI-DEPRESSANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/26/2007 | 61NIA76PAROXETINE (ANTI-DEPRESSANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zydus Lifesciences Limited's FDA import refusal history?
Zydus Lifesciences Limited (FEI: 3002984011) has 10 FDA import refusal record(s) in our database, spanning from 4/26/2007 to 11/17/2022.
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 Lifesciences Limited's FEI number is 3002984011.
What types of violations has Zydus Lifesciences Limited received?
Zydus Lifesciences 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 Zydus Lifesciences Limited come from?
All FDA import refusal data for Zydus Lifesciences 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.