What did the FDA find wrong with Olympus Medical Systems Corporation?

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

Are Olympus Medical Systems Corporation 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 Olympus Medical Systems Corporation products?

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

Olympus Medical Systems Corporation FDA Warning (2017)

Name: Olympus Medical Systems Corporation FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:20.786444

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 07, 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 Olympus Medical Systems Corporation on June 07, 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 Olympus Medical Systems Corporation's operations or product claims.

Potential Health Risks

Department of Health and Human Services

Valerie A. Flournoy, MSDeputy DirectorDivision of Manufacturing and QualityOffice of ComplianceCenter for Devices andRadiological Health Chief

Regulatory Context

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 12, 2015. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Olympus Medical Systems Corporation FDA Warning Letter

Frequently Asked Questions

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