Fagron Compounding Services LLC dba Fagron Sterile Services
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on November 28, 2017
Executive Summary
The FDA issued a warning letter to Fagron Compounding Services LLC dba Fagron Sterile Services on November 28, 2017 citing regulatory violations. The letter was issued by Detroit District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Fagron Compounding Services LLC dba Fagron Sterile Services's operations or product claims.
Potential Health Risks
Division of Pharmaceutical Quality Operations III300 River Place, Suite 5900Detroit, MI 48207Telephone: (313) 393-8100Fax: (313) 393-8139
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Fagron Compounding Services LLC dba Fagron Sterile Services?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Fagron Compounding Services LLC dba Fagron Sterile Services 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 Fagron Compounding Services LLC dba Fagron Sterile Services products?
- If you have used products from Fagron Compounding Services LLC dba Fagron Sterile Services 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