Zandu Pharmaceutical Works
⚠️ Moderate Risk
FEI: 3005056801 • Masat • 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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2017 | 60SCY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2009 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/31/2007 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zandu Pharmaceutical Works's FDA import refusal history?
Zandu Pharmaceutical Works (FEI: 3005056801) has 3 FDA import refusal record(s) in our database, spanning from 7/31/2007 to 10/17/2017.
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 Pharmaceutical Works's FEI number is 3005056801.
What types of violations has Zandu Pharmaceutical Works received?
Zandu Pharmaceutical Works 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 Zandu Pharmaceutical Works come from?
All FDA import refusal data for Zandu Pharmaceutical Works 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.