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SHREYA LIFE SCIENCES PVT LTD

⚠️ Moderate Risk

FEI: 3021021328 • Dist Harid • INDIA

FEI

FEI Number

3021021328

📍

Location

Dist Harid

🇮🇳

Country

INDIA
🏢

Address

Plot No 13/14/15 Villag, , Bhagwanpur,Dist Harid, , India

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/22/2021
Latest Refusal
12/22/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
4.9×20%
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
12/22/2021
56ECA20DOXYCYCLINE (TETRACYCLINES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHREYA LIFE SCIENCES PVT LTD's FDA import refusal history?

SHREYA LIFE SCIENCES PVT LTD (FEI: 3021021328) has 1 FDA import refusal record(s) in our database, spanning from 12/22/2021 to 12/22/2021.

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. SHREYA LIFE SCIENCES PVT LTD's FEI number is 3021021328.

What types of violations has SHREYA LIFE SCIENCES PVT LTD received?

SHREYA LIFE 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 SHREYA LIFE SCIENCES PVT LTD come from?

All FDA import refusal data for SHREYA LIFE 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.