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MAC BIO SCIENCES PVT LTD

⚠️ High Risk

FEI: 3032736945 • Barwala Panchku • INDIA

FEI

FEI Number

3032736945

📍

Location

Barwala Panchku

🇮🇳

Country

INDIA
🏢

Address

Plot No 262 Hsiidc Alip, , Barwala Panchku, , India

High Risk

FDA Import Risk Assessment

55.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/15/2024
Latest Refusal
11/15/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
76.6×20%
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
11/15/2024
66FDY99SUPPRESSANT N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MAC BIO SCIENCES PVT LTD's FDA import refusal history?

MAC BIO SCIENCES PVT LTD (FEI: 3032736945) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2024 to 11/15/2024.

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. MAC BIO SCIENCES PVT LTD's FEI number is 3032736945.

What types of violations has MAC BIO SCIENCES PVT LTD received?

MAC BIO SCIENCES 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 MAC BIO SCIENCES PVT LTD come from?

All FDA import refusal data for MAC BIO SCIENCES 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.