Ipca Laboratories Limited
⚠️ Moderate Risk
FEI: 3005977675 • Silvassa, Dadra and Nagar Haveli and Dam • INDIA
FEI Number
3005977675
Location
Silvassa, Dadra and Nagar Haveli and Dam
Country
INDIAAddress
Plot No. 65, 99 and 126, Danudyog Industrial Estate, Piparia, , Silvassa, Dadra and Nagar Haveli and Dam, 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
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 |
|---|---|---|---|
| 4/18/2023 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ipca Laboratories Limited's FDA import refusal history?
Ipca Laboratories Limited (FEI: 3005977675) has 1 FDA import refusal record(s) in our database, spanning from 4/18/2023 to 4/18/2023.
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. Ipca Laboratories Limited's FEI number is 3005977675.
What types of violations has Ipca Laboratories Limited received?
Ipca Laboratories Limited 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 Ipca Laboratories Limited come from?
All FDA import refusal data for Ipca Laboratories 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.