Aspen Surgical Products, Inc.
⚠️ Moderate Risk
FEI: 3002750084 • Caledonia, MI • UNITED STATES
FEI Number
3002750084
Location
Caledonia, MI
Country
UNITED STATESAddress
6945 Southbelt Dr Se, , Caledonia, MI, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Aspen Surgical Products, Inc.'s FDA import refusal history?
Aspen Surgical Products, Inc. (FEI: 3002750084) has 2 FDA import refusal record(s) in our database, spanning from 8/16/2013 to 9/10/2013.
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. Aspen Surgical Products, Inc.'s FEI number is 3002750084.
What types of violations has Aspen Surgical Products, Inc. received?
Aspen Surgical Products, 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 Aspen Surgical Products, Inc. come from?
All FDA import refusal data for Aspen Surgical Products, 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.