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Pharmazell (India) Private Limited

⚠️ Moderate Risk

FEI: 3003602532 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3003602532

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

& B6 A1 & A2 Plot No B5, Tambaram, Chennai, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/29/2008
Latest Refusal
9/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

751×

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
9/29/2008
65BCS03CARBOCYSTEINE (MUCOLYTIC)
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pharmazell (India) Private Limited's FDA import refusal history?

Pharmazell (India) Private Limited (FEI: 3003602532) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2008 to 9/29/2008.

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. Pharmazell (India) Private Limited's FEI number is 3003602532.

What types of violations has Pharmazell (India) Private Limited received?

Pharmazell (India) Private Limited 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 Pharmazell (India) Private Limited come from?

All FDA import refusal data for Pharmazell (India) Private 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.