WEST COAST PHARMACEUTICAL WORKS LTD.
⚠️ High Risk
FEI: 3008456809 • Ahmedabad, Gujarat • INDIA
FEI Number
3008456809
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Meldi Estate, Nr Prasang Party Plot, Sayonacity Road, Gota, Ahmedabad, Gujarat, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is WEST COAST PHARMACEUTICAL WORKS LTD.'s FDA import refusal history?
WEST COAST PHARMACEUTICAL WORKS LTD. (FEI: 3008456809) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2024 to 5/17/2024.
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. WEST COAST PHARMACEUTICAL WORKS LTD.'s FEI number is 3008456809.
What types of violations has WEST COAST PHARMACEUTICAL WORKS LTD. received?
WEST COAST PHARMACEUTICAL WORKS LTD. has been cited for 1 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 WEST COAST PHARMACEUTICAL WORKS LTD. come from?
All FDA import refusal data for WEST COAST PHARMACEUTICAL 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.