Sucesores De Esmoris & Co., Inc. FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 02, 2018
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.
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
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