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Apitoria Pharma Private Limited

⚠️ Moderate Risk

FEI: 3004086884 • Sangareddy District, Telangana • INDIA

FEI

FEI Number

3004086884

📍

Location

Sangareddy District, Telangana

🇮🇳

Country

INDIA
🏢

Address

Survey No. 10 & 13, Gaddapotharam Village, Ida-Kazipally, Jinnaram Mandal, Sangareddy District, Telangana, India

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/26/2017
Latest Refusal
8/8/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.5×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
5/26/2017
66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
16DIRECTIONS
Division of Northeast Imports (DNEI)
8/8/2011
62OCS22CARVEDILOL (ANTI-HYPERTENSIVE - PART II)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Apitoria Pharma Private Limited's FDA import refusal history?

Apitoria Pharma Private Limited (FEI: 3004086884) has 2 FDA import refusal record(s) in our database, spanning from 8/8/2011 to 5/26/2017.

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. Apitoria Pharma Private Limited's FEI number is 3004086884.

What types of violations has Apitoria Pharma Private Limited received?

Apitoria Pharma Private Limited 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 Apitoria Pharma Private Limited come from?

All FDA import refusal data for Apitoria Pharma Private Limited 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.