What did the FDA find wrong with Sekisui Medical Co., Ltd.?

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

Are Sekisui Medical Co., Ltd. products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.

What should I do if I've used Sekisui Medical Co., Ltd. products?

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

Sekisui Medical Co., Ltd. FDA Warning (2017)

Name: Sekisui Medical Co., Ltd. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.252724

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on October 05, 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 Sekisui Medical Co., Ltd. on October 05, 2017 citing cgmp violations. The letter was issued by the FDA.

CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Sekisui Medical Co., Ltd.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Sekisui Medical Co., Ltd..

Regulatory Context

Mr. Homare Tachiyanagi, General ManagerSekisui Medical Co. Ltd.Iwate Fractory4-11 5 MatsuoHachimantai. Iwate. 028-7305Japan

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-04 dated November 8, 2016. Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter docs 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 FDA expects you and your firm to maintain compliance with current good manufacturing practices and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means.

Key Entities Identified

Sekisui Medical Co. Ltd. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Sekisui Medical Co., Ltd.?: The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
Are Sekisui Medical Co., Ltd. products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
What should I do if I've used Sekisui Medical Co., Ltd. products?: If you have used products from Sekisui Medical Co., Ltd. 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.