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Carl Zeiss Meditec Production, LLC

⚠️ Moderate Risk

FEI: 3010126268 • Ontario, CA • UNITED STATES

FEI

FEI Number

3010126268

📍

Location

Ontario, CA

🇺🇸
🏢

Address

1040 S Vintage Ave Ste A, , Ontario, CA, United States

Moderate Risk

FDA Import Risk Assessment

39.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
6/9/2015
Latest Refusal
6/9/2015
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

2375×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
6/9/2015
86HQLLENS, INTRAOCULAR
118NOT LISTED
237NO PMA
Seattle District Office (SEA-DO)
6/9/2015
86HQLLENS, INTRAOCULAR
118NOT LISTED
237NO PMA
Seattle District Office (SEA-DO)
6/9/2015
86HQLLENS, INTRAOCULAR
118NOT LISTED
237NO PMA
Seattle District Office (SEA-DO)
6/9/2015
86HQLLENS, INTRAOCULAR
118NOT LISTED
237NO PMA
Seattle District Office (SEA-DO)
6/9/2015
86HQLLENS, INTRAOCULAR
118NOT LISTED
237NO PMA
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Carl Zeiss Meditec Production, LLC's FDA import refusal history?

Carl Zeiss Meditec Production, LLC (FEI: 3010126268) has 5 FDA import refusal record(s) in our database, spanning from 6/9/2015 to 6/9/2015.

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. Carl Zeiss Meditec Production, LLC's FEI number is 3010126268.

What types of violations has Carl Zeiss Meditec Production, LLC received?

Carl Zeiss Meditec Production, LLC 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 Carl Zeiss Meditec Production, LLC come from?

All FDA import refusal data for Carl Zeiss Meditec Production, LLC 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.