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Caplin Point Lab Ltd

⚠️ Moderate Risk

FEI: 3006948036 • Tamil Nadu • INDIA

FEI

FEI Number

3006948036

📍

Location

Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

3 Lakshmanan Street, , Tamil Nadu, , India

Moderate Risk

FDA Import Risk Assessment

45.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
10/27/2011
Latest Refusal
6/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
22.6×10%
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

753×

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
10/27/2011
56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/27/2011
61FDA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/29/2010
62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Caplin Point Lab Ltd's FDA import refusal history?

Caplin Point Lab Ltd (FEI: 3006948036) has 3 FDA import refusal record(s) in our database, spanning from 6/29/2010 to 10/27/2011.

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. Caplin Point Lab Ltd's FEI number is 3006948036.

What types of violations has Caplin Point Lab Ltd received?

Caplin Point Lab 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 Caplin Point Lab Ltd come from?

All FDA import refusal data for Caplin Point Lab 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.