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Civco Medical Instruments Co. Inc.

✅ Low Risk

FEI: 1937223 • Kalona, IA • UNITED STATES

FEI

FEI Number

1937223

📍

Location

Kalona, IA

🇺🇸
🏢

Address

102 1st St S, , Kalona, IA, United States

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/29/2013
Latest Refusal
3/29/2013
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/29/2013
90OIJBIOPSY NEEDLE GUIDE KIT
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Civco Medical Instruments Co. Inc.'s FDA import refusal history?

Civco Medical Instruments Co. Inc. (FEI: 1937223) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2013 to 3/29/2013.

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. Civco Medical Instruments Co. Inc.'s FEI number is 1937223.

What types of violations has Civco Medical Instruments Co. Inc. received?

Civco Medical Instruments Co. Inc. 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 Civco Medical Instruments Co. Inc. come from?

All FDA import refusal data for Civco Medical Instruments Co. 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.