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Handy-Waterbase India Private Ltd.

⚠️ Moderate Risk

FEI: 3004323875 • Tuticorin, Tamil Nadu • INDIA

FEI

FEI Number

3004323875

📍

Location

Tuticorin, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

Plot C-3 Sipcot Industrial Complex, Madathur Post, Tuticorin, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

44.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/14/2004
Latest Refusal
7/8/2004
Earliest Refusal

Score Breakdown

Violation Severity
87.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

28602×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

30601×

POIS CHLOR

The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health.

Refusal History

DateProductViolationsDivision
10/14/2004
16JEO01CRAB
238UNSAFE ADD
3060POIS CHLOR
Baltimore District Office (BLT-DO)
9/3/2004
16JEO01CRAB
2860VETDRUGRES
Baltimore District Office (BLT-DO)
7/8/2004
16JEO01CRAB
2860VETDRUGRES
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Handy-Waterbase India Private Ltd.'s FDA import refusal history?

Handy-Waterbase India Private Ltd. (FEI: 3004323875) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2004 to 10/14/2004.

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. Handy-Waterbase India Private Ltd.'s FEI number is 3004323875.

What types of violations has Handy-Waterbase India Private Ltd. received?

Handy-Waterbase India Private Ltd. has been cited for 3 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 Handy-Waterbase India Private Ltd. come from?

All FDA import refusal data for Handy-Waterbase India Private 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.