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CIPLA LTD

⚠️ High Risk

FEI: 3014316990 • Mumabai • INDIA

FEI

FEI Number

3014316990

📍

Location

Mumabai

🇮🇳

Country

INDIA
🏢

Address

Bldg No E-4, Mumbai Nasik Highway, Mumabai, , India

High Risk

FDA Import Risk Assessment

55.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

4
Total Refusals
1
Unique Violations
9/5/2023
Latest Refusal
9/5/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
38.2×20%
Frequency
40.0×10%
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

754×

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

DateProductViolationsDivision
9/5/2023
66NAY99TRANQUILIZER (ANTI-PSYCHOTIC) - PART II N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/5/2023
61HAY99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/5/2023
61MAY99ANTI-CONVULSANT, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/5/2023
62CAY99ANTI-HYPERTENSIVE N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CIPLA LTD's FDA import refusal history?

CIPLA LTD (FEI: 3014316990) has 4 FDA import refusal record(s) in our database, spanning from 9/5/2023 to 9/5/2023.

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. CIPLA LTD's FEI number is 3014316990.

What types of violations has CIPLA LTD received?

CIPLA 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 CIPLA LTD come from?

All FDA import refusal data for CIPLA 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.