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Tower Laboratories, Ltd.

✅ Low Risk

FEI: 3005596071 • Clinton, CT • UNITED STATES

FEI

FEI Number

3005596071

📍

Location

Clinton, CT

🇺🇸
🏢

Address

7 Heritage Park Rd, , Clinton, CT, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/21/2018
Latest Refusal
8/21/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
8/21/2018
76EFTCLEANSER, DENTURE, OTC
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Tower Laboratories, Ltd.'s FDA import refusal history?

Tower Laboratories, Ltd. (FEI: 3005596071) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2018 to 8/21/2018.

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. Tower Laboratories, Ltd.'s FEI number is 3005596071.

What types of violations has Tower Laboratories, Ltd. received?

Tower Laboratories, Ltd. has been cited for 1 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 Tower Laboratories, Ltd. come from?

All FDA import refusal data for Tower Laboratories, 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.