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Central Alberta Compounding Centre

⚠️ Moderate Risk

FEI: 3006996977 • Red Deer, AB • CANADA

FEI

FEI Number

3006996977

📍

Location

Red Deer, AB

🇨🇦

Country

CANADA
🏢

Address

3617-50 Avenue, , Red Deer, AB, Canada

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/11/2008
Latest Refusal
7/11/2008
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

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).

752×

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
7/11/2008
64GIK99ESTROGEN N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
7/11/2008
64GIK08ESTRADIOL BENZOATE (ESTROGEN)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Central Alberta Compounding Centre's FDA import refusal history?

Central Alberta Compounding Centre (FEI: 3006996977) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2008 to 7/11/2008.

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. Central Alberta Compounding Centre's FEI number is 3006996977.

What types of violations has Central Alberta Compounding Centre received?

Central Alberta Compounding Centre 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 Central Alberta Compounding Centre come from?

All FDA import refusal data for Central Alberta Compounding Centre 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.