Zydus Lifesciences Limited
⚠️ Moderate Risk
FEI: 3006595385 • Ahmedabad, Gujarat • INDIA
FEI Number
3006595385
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Blocks 265,266,267, Opp. Laxminarayan Petrol Pump, Sarkhej-Bavla National Highway, 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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 6/22/2011 | 62JCA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | New Orleans District Office (NOL-DO) | |
| 1/21/2011 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/25/2010 | 62KBC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/24/2009 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/28/2009 | 60CDR21EPHEDRINE (ADRENERGIC) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 12/13/2006 | 62OCC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zydus Lifesciences Limited's FDA import refusal history?
Zydus Lifesciences Limited (FEI: 3006595385) has 11 FDA import refusal record(s) in our database, spanning from 12/13/2006 to 6/22/2011.
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 3006595385.
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.