Zandu Pharamceutical Works Ltd
⚠️ Moderate Risk
FEI: 1000282433 • Mumbai, Maharashtra • INDIA
FEI Number
1000282433
Location
Mumbai, Maharashtra
Country
INDIAAddress
70 Gokhale Road South, , Mumbai, Maharashtra, 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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2008 | 54FCJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/31/2005 | 61WBE99A-FUNGAL N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/27/2005 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/7/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zandu Pharamceutical Works Ltd's FDA import refusal history?
Zandu Pharamceutical Works Ltd (FEI: 1000282433) has 4 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 3/19/2008.
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. Zandu Pharamceutical Works Ltd's FEI number is 1000282433.
What types of violations has Zandu Pharamceutical Works Ltd received?
Zandu Pharamceutical Works Ltd 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 Zandu Pharamceutical Works Ltd come from?
All FDA import refusal data for Zandu Pharamceutical Works 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.