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Fresenius Medical Care Holdings, Inc.

⚠️ Moderate Risk

FEI: 3001451489 • Waltham, MA • UNITED STATES

FEI

FEI Number

3001451489

📍

Location

Waltham, MA

🇺🇸
🏢

Address

920 Winter St Bld 920, , Waltham, MA, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/18/2012
Latest Refusal
9/18/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
9/18/2012
78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
2780DEVICEGMPS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Fresenius Medical Care Holdings, Inc.'s FDA import refusal history?

Fresenius Medical Care Holdings, Inc. (FEI: 3001451489) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2012 to 9/18/2012.

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. Fresenius Medical Care Holdings, Inc.'s FEI number is 3001451489.

What types of violations has Fresenius Medical Care Holdings, Inc. received?

Fresenius Medical Care Holdings, 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 Fresenius Medical Care Holdings, Inc. come from?

All FDA import refusal data for Fresenius Medical Care Holdings, 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.