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...