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ZEELAB PHARMACY PVT LTD

⚠️ High Risk

FEI: 3030408696 • New Delhi, Delhi • INDIA

FEI

FEI Number

3030408696

📍

Location

New Delhi, Delhi

🇮🇳

Country

INDIA
🏢

Address

913 D Mall, Ring Road, New Delhi, Delhi, India

High Risk

FDA Import Risk Assessment

54.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/11/2025
Latest Refusal
3/24/2025
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
81.7×20%
Frequency
20.0×10%
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

752×

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).

1181×

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

DateProductViolationsDivision
6/11/2025
62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/24/2025
61NDA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ZEELAB PHARMACY PVT LTD's FDA import refusal history?

ZEELAB PHARMACY PVT LTD (FEI: 3030408696) has 2 FDA import refusal record(s) in our database, spanning from 3/24/2025 to 6/11/2025.

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. ZEELAB PHARMACY PVT LTD's FEI number is 3030408696.

What types of violations has ZEELAB PHARMACY PVT LTD received?

ZEELAB PHARMACY PVT LTD has been cited for 2 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 ZEELAB PHARMACY PVT LTD come from?

All FDA import refusal data for ZEELAB PHARMACY PVT 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.