What did the FDA find wrong with Pentax of America, Inc.?

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

Are Pentax of America, 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 Pentax of America, Inc. products?

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

Pentax of America, Inc. FDA Warning (2018)

Name: Pentax of America, Inc. FDA Warning (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:25.011157

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 26, 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 Pentax of America, Inc. on January 26, 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 Pentax of America, Inc.'s operations or product claims.

Potential Health Risks

Office of Medical Device and Radiological Health Operations (Division 1)One Montvale AvenueStoneham, MA 02180

Gina BrackettActing Director, Compliance BranchOffice of Medical Device and Radiological Health Operations, Division 1

Regulatory Context

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to the Warning Letter [13-NWJ-06, dated March 29, 2013], issued to KayPENTAX, A Division of PENTAX Medical Company. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does 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 Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Pentax of America Inc. FDA Warning Letter

Frequently Asked Questions

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