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MSD PHARMACEUTICALS PVT. LTD

⚠️ Moderate Risk

FEI: 3015447861 • Bangalore • INDIA

FEI

FEI Number

3015447861

📍

Location

Bangalore

🇮🇳

Country

INDIA
🏢

Address

Khata No., 847/713 And, , Bangalore, , India

Moderate Risk

FDA Import Risk Assessment

48.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
4/11/2022
Latest Refusal
12/11/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
10.2×20%
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

754×

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
4/11/2022
61PDY26METFORMIN (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/19/2021
61PDY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/19/2021
61PCE26METFORMIN (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/11/2020
61PDY99ANTI-DIABETIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MSD PHARMACEUTICALS PVT. LTD's FDA import refusal history?

MSD PHARMACEUTICALS PVT. LTD (FEI: 3015447861) has 4 FDA import refusal record(s) in our database, spanning from 12/11/2020 to 4/11/2022.

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. MSD PHARMACEUTICALS PVT. LTD's FEI number is 3015447861.

What types of violations has MSD PHARMACEUTICALS PVT. LTD received?

MSD PHARMACEUTICALS 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 MSD PHARMACEUTICALS PVT. LTD come from?

All FDA import refusal data for MSD PHARMACEUTICALS 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.