What did the FDA find wrong with Meditech Laboratories, Inc?

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

Are Meditech Laboratories, 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 Meditech Laboratories, Inc products?

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

Meditech Laboratories, Inc FDA Warning (2017)

Name: Meditech Laboratories, Inc FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.268793

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 06, 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 Meditech Laboratories, Inc on December 06, 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 Meditech Laboratories, Inc's operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations IV19701 Fairchild Road, Irvine, CA 92612-2506

Michael B. Bitar, PharmD, Pharmacist-in-ChargeMeditech Laboratories, Inc.3200 Polaris Ave Suite #27Las Vegas, NV 89102

Mark C. SaaleActing Director, Compliance BranchDivision of Pharmaceutical Quality Operations IV

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 (Reference No. CMS 506537) dated October 19, 2016. We acknowledge that your firm no longer produces sterile drug products. 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. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Meditech Laboratories Inc FDA Warning Letter

Frequently Asked Questions

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