What did the FDA find wrong with Lincare, Inc.?

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

Are Lincare, 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 Lincare, Inc. products?

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

Is Lincare, Inc. Safe? FDA Warning Letter Review (2018)

Name: Is Lincare, Inc. Safe? FDA Warning Letter Review (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:25.775963

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 05, 2018

MODERATE SEVERITY 2018

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 Lincare, Inc. on March 05, 2018 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 Lincare, Inc.'s operations or product claims.

Potential Health Risks

Office of Pharmaceutical Quality Operations, Division II4040 N. Central Expressway, Suite 300Dallas, Texas 75204

LCDR John W. Diehl, M.S.Director, Compliance BranchOffice of Pharmaceutical Quality Operations, Division II

Regulatory Context

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #2016-DAL-WL-19 dated April 25, 2016. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have any further questions, you may contact me at(214) 253-5288.

Key Entities Identified

Lincare Inc. FDA Warning Letter

Frequently Asked Questions

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