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Honeywell Healthcare Solutions GmbH (formerly EnviteC)

⚠️ Moderate Risk

FEI: 1000352675 • Wismar, Mecklenburg-Western-Pommerania • GERMANY

FEI

FEI Number

1000352675

📍

Location

Wismar, Mecklenburg-Western-Pommerania

🇩🇪

Country

GERMANY
🏢

Address

Alter Holzhafen 18, , Wismar, Mecklenburg-Western-Pommerania, Germany

Moderate Risk

FDA Import Risk Assessment

27.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
9/11/2020
Latest Refusal
3/16/2002
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
1.6×10%
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

1182×

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).

2371×

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).

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
9/11/2020
73BXPTRANSDUCER, GAS FLOW
341REGISTERED
Division of Southeast Imports (DSEI)
7/21/2006
91MGXTEST SYSTEM, FOR DRUGS OF ABUSE
118NOT LISTED
237NO PMA
New Orleans District Office (NOL-DO)
3/16/2002
74DQAOXIMETER
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Honeywell Healthcare Solutions GmbH (formerly EnviteC)'s FDA import refusal history?

Honeywell Healthcare Solutions GmbH (formerly EnviteC) (FEI: 1000352675) has 3 FDA import refusal record(s) in our database, spanning from 3/16/2002 to 9/11/2020.

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. Honeywell Healthcare Solutions GmbH (formerly EnviteC)'s FEI number is 1000352675.

What types of violations has Honeywell Healthcare Solutions GmbH (formerly EnviteC) received?

Honeywell Healthcare Solutions GmbH (formerly EnviteC) 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 Honeywell Healthcare Solutions GmbH (formerly EnviteC) come from?

All FDA import refusal data for Honeywell Healthcare Solutions GmbH (formerly EnviteC) 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.