ImportRefusal LogoImportRefusal

Pharmaceutical Innovations, Inc.

⚠️ Moderate Risk

FEI: 2241583 • Newark, NJ • UNITED STATES

FEI

FEI Number

2241583

📍

Location

Newark, NJ

🇺🇸
🏢

Address

897 Frelinghuysen Ave, , Newark, NJ, United States

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/21/2018
Latest Refusal
2/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
22.3×30%
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

782×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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.

1181×

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
9/21/2018
90MUIMEDIA, COUPLING, ULTRASOUND
78STERILITY
Division of Southwest Imports (DSWI)
5/30/2018
90MUIMEDIA, COUPLING, ULTRASOUND
78STERILITY
Division of Southwest Imports (DSWI)
2/26/2010
80KMJLUBRICANT, PATIENT
118NOT LISTED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Pharmaceutical Innovations, Inc.'s FDA import refusal history?

Pharmaceutical Innovations, Inc. (FEI: 2241583) has 3 FDA import refusal record(s) in our database, spanning from 2/26/2010 to 9/21/2018.

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. Pharmaceutical Innovations, Inc.'s FEI number is 2241583.

What types of violations has Pharmaceutical Innovations, Inc. received?

Pharmaceutical Innovations, Inc. 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 Pharmaceutical Innovations, Inc. come from?

All FDA import refusal data for Pharmaceutical Innovations, Inc. 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.