What did the FDA find wrong with Elite Laboratories Inc.?

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

Are Elite 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 Elite Laboratories Inc. products?

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

Elite Laboratories Inc. FDA Warning (2017)

Name: Elite Laboratories Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.193924

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 15, 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 Elite Laboratories Inc. on December 15, 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 Elite Laboratories Inc.'s operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FLParsippany, NJ 07054Telephone:(973) 331-4900FAX:(973) 331-4969

Regulatory Context

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-NWJ-13, dated August 25, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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.

Yvette JohnsonCompliance Officer – PHRM1-CB

Key Entities Identified

Elite Laboratories Inc. FDA Warning Letter

Frequently Asked Questions

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