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BIPHA DRUG LABORATORIES PVT LTD

⚠️ Moderate Risk

FEI: 3014615198 • Kottayam • INDIA

FEI

FEI Number

3014615198

📍

Location

Kottayam

🇮🇳

Country

INDIA
🏢

Address

Xiii/804 D, Pallipurath, , Kottayam, , India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/11/2018
Latest Refusal
10/11/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
10/11/2018
55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIPHA DRUG LABORATORIES PVT LTD's FDA import refusal history?

BIPHA DRUG LABORATORIES PVT LTD (FEI: 3014615198) has 1 FDA import refusal record(s) in our database, spanning from 10/11/2018 to 10/11/2018.

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. BIPHA DRUG LABORATORIES PVT LTD's FEI number is 3014615198.

What types of violations has BIPHA DRUG LABORATORIES PVT LTD received?

BIPHA DRUG LABORATORIES PVT 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 BIPHA DRUG LABORATORIES PVT LTD come from?

All FDA import refusal data for BIPHA DRUG LABORATORIES 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.