ImportRefusal LogoImportRefusal

IVD, LLC

⚠️ Moderate Risk

FEI: 1000135987 • Philadelphia, PA • UNITED STATES

FEI

FEI Number

1000135987

📍

Location

Philadelphia, PA

🇺🇸
🏢

Address

10101 Roosevelt Blvd, , Philadelphia, PA, United States

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
6/21/2011
Latest Refusal
5/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

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).

Refusal History

DateProductViolationsDivision
6/21/2011
54BBA07IRON (MINERAL)
27DRUG GMPS
New York District Office (NYK-DO)
5/16/2011
54BBT01CALCIUM (MINERAL)
11UNSAFE COL
218LIST INGRE
New York District Office (NYK-DO)

Frequently Asked Questions

What is IVD, LLC's FDA import refusal history?

IVD, LLC (FEI: 1000135987) has 2 FDA import refusal record(s) in our database, spanning from 5/16/2011 to 6/21/2011.

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. IVD, LLC's FEI number is 1000135987.

What types of violations has IVD, LLC received?

IVD, LLC has been cited for 3 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 IVD, LLC come from?

All FDA import refusal data for IVD, LLC 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.