HBW Insight is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Liberty Enterprises

This article was originally published in The Rose Sheet

Executive Summary

Liberty Enterprises: Developing written stability program to "assure the continued effectiveness of p-chloro-m-xylenol" throughout the shelf life of the company's Liberty Antimicrobial Lotion hand soap, Liberty states in a response to an FDA warning letter. The agency had stated that the antibacterial soap that Liberty repacked in-house was adulterated because it lacks a written stability testing program for p-chloro-m-xylenol, a preservative. In addition, FDA pointed out that Liberty had no information regarding the soap's stability in "the container-closure system in which it is marketed" and "lack[ed] assurance" that the finished product contains the preservative at the level specified on the product's label. Liberty also said that it is in the process of validating the product's stability and that it would obtain certificates of analysis for incoming bulk batches of the antimicrobial soap to guarantee p-chloro-m-xylenol levels...
Advertisement
Advertisement
UsernamePublicRestriction

Register

RS003299

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel