ImportRefusal LogoImportRefusal

Padmanabha Raju

⚠️ Moderate Risk

FEI: 3010459951 • Andhra Pradesh • INDIA

FEI

FEI Number

3010459951

📍

Location

Andhra Pradesh

🇮🇳

Country

INDIA
🏢

Address

Bhimavaram, , Andhra Pradesh, , India

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/29/2013
Latest Refusal
11/29/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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
11/29/2013
65RCY18SODIUM BICARBONATE (REPLENISHER)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/29/2013
54AFY17BIOTIN (VITAMIN H, COENZYME R)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/29/2013
62ACY04CALCITRIOL (ANTI-HYPERCALCEMIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/29/2013
62OCY05RAMIPRIL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Padmanabha Raju's FDA import refusal history?

Padmanabha Raju (FEI: 3010459951) has 4 FDA import refusal record(s) in our database, spanning from 11/29/2013 to 11/29/2013.

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. Padmanabha Raju's FEI number is 3010459951.

What types of violations has Padmanabha Raju received?

Padmanabha Raju 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 Padmanabha Raju come from?

All FDA import refusal data for Padmanabha Raju 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.