Yusef Manufacturing Laboratories, LLC FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 25, 2017
Executive Summary
The FDA issued a warning letter to Yusef Manufacturing Laboratories, LLC on May 25, 2017 citing regulatory violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Yusef Manufacturing Laboratories, LLC's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Yusef Manufacturing Laboratories, LLC.
Regulatory Context
an action plan and timelines for testing all in-date drug products for identity and strength of active ingredients, and all other appropriate chemical and microbiological quality attributes (e.g., total count, objectionable microorganisms). Regarding drug products found to be of substandard quality, including YMLabs Aloe Gel Sanitizers (62% ethyl alcohol) and SPF 15 sunscreen lip balm products, specify the actions that you will take, such as notifying customers and product recalls.
to ensure appropriate design, control, maintenance, and monitoring of your manufacturing processes and water system
for validating your water system and your drug product manufacturing processes
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Yusef Manufacturing Laboratories, LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Yusef Manufacturing Laboratories, LLC 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 Yusef Manufacturing Laboratories, LLC products?
- If you have used products from Yusef Manufacturing Laboratories, LLC 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