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Veranova LP

⚠️ Moderate Risk

FEI: 2245277 • West Deptford, NJ • UNITED STATES

FEI

FEI Number

2245277

📍

Location

West Deptford, NJ

🇺🇸
🏢

Address

2003 Nolte Dr, , West Deptford, NJ, United States

Moderate Risk

FDA Import Risk Assessment

35.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
3/26/2020
Latest Refusal
3/26/2020
Earliest Refusal

Score Breakdown

Violation Severity
78.0×40%
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

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).

161×

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.

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.

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

3321×

CONTAINER

The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.

Refusal History

DateProductViolationsDivision
3/26/2020
62ZAS01CARBOPLATIN (ANTI-NEOPLASTIC - PART II)
118NOT LISTED
16DIRECTIONS
186INSANITARY
27DRUG GMPS
332CONTAINER
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Veranova LP's FDA import refusal history?

Veranova LP (FEI: 2245277) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2020 to 3/26/2020.

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. Veranova LP's FEI number is 2245277.

What types of violations has Veranova LP received?

Veranova LP has been cited for 5 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 Veranova LP come from?

All FDA import refusal data for Veranova LP 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.