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ALAINA HEALTH CARE PVT LTD

⚠️ High Risk

FEI: 3030866788 • Baddi, Himachal Pradesh • INDIA

FEI

FEI Number

3030866788

📍

Location

Baddi, Himachal Pradesh

🇮🇳

Country

INDIA
🏢

Address

132 707 1 Khasra No 127, , Baddi, Himachal Pradesh, India

High Risk

FDA Import Risk Assessment

58.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/25/2025
Latest Refusal
9/20/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
76.0×20%
Frequency
20.0×10%
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

752×

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
7/25/2025
62FDO34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/20/2024
66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ALAINA HEALTH CARE PVT LTD's FDA import refusal history?

ALAINA HEALTH CARE PVT LTD (FEI: 3030866788) has 2 FDA import refusal record(s) in our database, spanning from 9/20/2024 to 7/25/2025.

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. ALAINA HEALTH CARE PVT LTD's FEI number is 3030866788.

What types of violations has ALAINA HEALTH CARE PVT LTD received?

ALAINA HEALTH CARE 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 ALAINA HEALTH CARE PVT LTD come from?

All FDA import refusal data for ALAINA HEALTH CARE 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.