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Proactol Ltd

⚠️ Moderate Risk

FEI: 3009544954 • Port Dundas Glasgow • UNITED KINGDOM

FEI

FEI Number

3009544954

📍

Location

Port Dundas Glasgow

🇬🇧
🏢

Address

12 Payne Street, , Port Dundas Glasgow, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/30/2012
Latest Refusal
6/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

4882×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

Refusal History

DateProductViolationsDivision
10/30/2012
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
488HEALTH C
Cincinnati District Office (CIN-DO)
6/27/2012
54FCC99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
488HEALTH C
New York District Office (NYK-DO)

Frequently Asked Questions

What is Proactol Ltd's FDA import refusal history?

Proactol Ltd (FEI: 3009544954) has 2 FDA import refusal record(s) in our database, spanning from 6/27/2012 to 10/30/2012.

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. Proactol Ltd's FEI number is 3009544954.

What types of violations has Proactol Ltd received?

Proactol Ltd 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 Proactol Ltd come from?

All FDA import refusal data for Proactol Ltd 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.