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Sucesores De Esmoris & Co., Inc. FDA Warning (2018)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 02, 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 Sucesores De Esmoris & Co., Inc. on January 02, 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 Sucesores De Esmoris & Co., Inc.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Sucesores De Esmoris & Co., Inc..

Regulatory Context

Office ofOffice of Human and Animal Food OperationsEast Division IVCompliance Branch466 Avenida Fernández JuncosSan Juan, Puerto Rico 00901-3223Tel: (787) 729-850

Office of Regulatory AffairsOffice of Human and Animal Food OperationsEast Division IVCompliance Branch466 Avenida Fernández JuncosSan Juan, Puerto Rico 00901-3223Tel:(787) 729-8500

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, 17-SJN-WL-05, dated 03/07/2017. It appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Key Entities Identified

Sucesores De Esmoris & Co. Inc. FDA Warning Letter

Frequently Asked Questions

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