What did the FDA find wrong with Option Care?

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

Are Option Care 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 Option Care products?

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

Is Option Care Safe? FDA Warning Letter Review (2018)

Name: Is Option Care Safe? FDA Warning Letter Review (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:26.436902

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 12, 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 Option Care on April 12, 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 Option Care's operations or product claims.

Potential Health Risks

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 [Ref: 2017-DAL-WL-01] issued on October 19, 2016, following our inspection of your facility, Option Care, Inc., located at 14220 Northbrook Drive, Suite 100B, San Antonio, Texas 78232, from July 20, 2015 to August 6, 2015. 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 questions regarding this letter, please contact me at214-253-5288or via email atJohn.Diehl@fda.hhs.gov.

Key Entities Identified

Option Care FDA Warning Letter

Frequently Asked Questions

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