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E.C. Moore Co.

⚠️ Moderate Risk

FEI: 1824299 • Dearborn, MI • UNITED STATES

FEI

FEI Number

1824299

📍

Location

Dearborn, MI

🇺🇸
🏢

Address

13325 Leonard St, , Dearborn, MI, United States

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/12/2005
Latest Refusal
3/11/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
19.9×10%
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

272×

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).

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).

Refusal History

DateProductViolationsDivision
9/12/2005
63TCJ99DENTAL RESTORATION AGENT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
5/12/2005
63TCJ99DENTAL RESTORATION AGENT N.E.C.
27DRUG GMPS
New York District Office (NYK-DO)
3/11/2004
63TCJ99DENTAL RESTORATION AGENT N.E.C.
27DRUG GMPS
New York District Office (NYK-DO)

Frequently Asked Questions

What is E.C. Moore Co.'s FDA import refusal history?

E.C. Moore Co. (FEI: 1824299) has 3 FDA import refusal record(s) in our database, spanning from 3/11/2004 to 9/12/2005.

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. E.C. Moore Co.'s FEI number is 1824299.

What types of violations has E.C. Moore Co. received?

E.C. Moore Co. 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 E.C. Moore Co. come from?

All FDA import refusal data for E.C. Moore Co. 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.