What did the FDA find wrong with King Systems Corp. dba Ambu, Inc.?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are King Systems Corp. dba Ambu, Inc. products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.

What should I do if I've used King Systems Corp. dba Ambu, Inc. products?

If you have used products from King Systems Corp. dba Ambu, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

King Systems Corp. dba Ambu, Inc. FDA Warning (2017)

Name: King Systems Corp. dba Ambu, Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:22.394038

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on October 04, 2017

MODERATE SEVERITY 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to King Systems Corp. dba Ambu, Inc. on October 04, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in King Systems Corp. dba Ambu, Inc.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from King Systems Corp. dba Ambu, Inc..

Regulatory Context

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 2013-DET-24 dated September 30, 2013. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,/S/Michael K. LarsonCompliance OfficerHuman and Animal Food Operations East 6Detroit District

Key Entities Identified

King Systems Corp. dba Ambu Inc. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with King Systems Corp. dba Ambu, Inc.?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are King Systems Corp. dba Ambu, Inc. products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used King Systems Corp. dba Ambu, Inc. products?: If you have used products from King Systems Corp. dba Ambu, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.