What did the FDA find wrong with Fresenius Kabi USA, LLC?

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

Are Fresenius Kabi USA, LLC 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 Fresenius Kabi USA, LLC products?

If you have used products from Fresenius Kabi USA, LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Fresenius Kabi USA, LLC FDA Warning (2017)

Name: Fresenius Kabi USA, LLC FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:19.882277

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 26, 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 Fresenius Kabi USA, LLC on July 26, 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 Fresenius Kabi USA, LLC's operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FLParsippany, NJ 07054Telephone: (973) 331-4900FAX: (973) 331-4969

/S/CDR Frank Verni, R.Ph.Compliance OfficerU.S. Food and Drug AdministrationNew York District OfficePharmaceutical Quality I Compliance Branch (PHRMl-CB)

Office of Pharmaceutical Quality Operations. Division of Pharmaceutical Quality Operations INew England District Office: One Montvale Avenue, 4th Floor Stoneham, MA 02180-3500T- (781) 587-7500 F- (781) 587-7556

Regulatory Context

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [NYK-2012-14 dated February 22, 2012]. 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.

Key Entities Identified

Fresenius Kabi USA LLC FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Fresenius Kabi USA, LLC?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Fresenius Kabi USA, LLC 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 Fresenius Kabi USA, LLC products?: If you have used products from Fresenius Kabi USA, LLC 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.