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Progressive Laboratories, Inc

⚠️ Moderate Risk

FEI: 1629365 • Irving, TX • UNITED STATES

FEI

FEI Number

1629365

📍

Location

Irving, TX

🇺🇸
🏢

Address

3131 Story Rd W, , Irving, TX, United States

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/21/2016
Latest Refusal
1/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

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
1/21/2016
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2280DIRSEXMPT
482NUTRIT LBL
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Progressive Laboratories, Inc's FDA import refusal history?

Progressive Laboratories, Inc (FEI: 1629365) has 1 FDA import refusal record(s) in our database, spanning from 1/21/2016 to 1/21/2016.

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. Progressive Laboratories, Inc's FEI number is 1629365.

What types of violations has Progressive Laboratories, Inc received?

Progressive Laboratories, Inc 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 Progressive Laboratories, Inc come from?

All FDA import refusal data for Progressive Laboratories, 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.