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P D Roy

⚠️ Moderate Risk

FEI: 3008328688 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3008328688

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

1 Chakala Road, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/24/2011
Latest Refusal
10/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

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
10/24/2011
61PDK17INSULIN (INJ) (ANTI-DIABETIC)
186INSANITARY
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is P D Roy's FDA import refusal history?

P D Roy (FEI: 3008328688) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2011 to 10/24/2011.

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. P D Roy's FEI number is 3008328688.

What types of violations has P D Roy received?

P D Roy has been cited for 2 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 P D Roy come from?

All FDA import refusal data for P D Roy 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.