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PIONEER HOMEO PHARMA PVT LTD

⚠️ Moderate Risk

FEI: 3026623859 • Hyderabad, Telangana • INDIA

FEI

FEI Number

3026623859

📍

Location

Hyderabad, Telangana

🇮🇳

Country

INDIA
🏢

Address

1 Plot No 529, Kakateeya Hills Road No 9; Road No 10, Hyderabad, Telangana, India

Moderate Risk

FDA Import Risk Assessment

39.7
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
4/7/2023
Latest Refusal
4/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
30.2×20%
Frequency
50.0×10%
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

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
4/7/2023
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Northern Border Imports (DNBI)
4/7/2023
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Northern Border Imports (DNBI)
4/7/2023
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Northern Border Imports (DNBI)
4/7/2023
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Northern Border Imports (DNBI)
4/7/2023
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is PIONEER HOMEO PHARMA PVT LTD's FDA import refusal history?

PIONEER HOMEO PHARMA PVT LTD (FEI: 3026623859) has 5 FDA import refusal record(s) in our database, spanning from 4/7/2023 to 4/7/2023.

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. PIONEER HOMEO PHARMA PVT LTD's FEI number is 3026623859.

What types of violations has PIONEER HOMEO PHARMA PVT LTD received?

PIONEER HOMEO PHARMA 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 PIONEER HOMEO PHARMA PVT LTD come from?

All FDA import refusal data for PIONEER HOMEO PHARMA 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.