FDA Asks for Proof from Toiletry Makers Gilchrist & Soames of Fixed Contamination ProblemsApr 18, 2016
The U.S. Food and Drug Administration (FDA) has sent a letter to luxury hotel toiletry maker Gilchrist & Soames (G&S) asking for proof that it has cleaned up its product operations as promised in 2015. At that time, G&S conducted a voluntary recall of over 2 million products including shampoos and shower gels suspected of harmful bacterial contamination, according to the Indianapolis Business Journal.
In March 2016, the FDA sent a letter asking for proof of corrective actions. G&S has since recalled more of its products after microbial contamination was found. The affected products are Gilchrist & Soames Therapy conditioning shampoo, shower gel, Pelican Hill Shower gel, and Essential Elements shampoo, CNN reports.
The recall follows the FDA's finding of "poisonous or deleterious substances" that are potentially harmful to human health. One of the pathogens found is known to be highly resistant to antibacterial agents causing the possibility of life-threatening infections. Additional bacteria found in these products may increase the risk of infection, especially in people with compromised immune systems.
In September and October 2015, an inspection of the Plainfield plant found insanitary practices that the FDA remarked could lead to contaminated products, the Indianapolis Business Journal reports.
In the FDA letter to president and CEO of G&S, Kathie DeVoe, it said, "Your firm does not perform any microbial testing on any raw materials, nor have you validated your suppliers' quality testing through independent verification." G&S was advised to develop a plan that would prevent the recurrence of these violations, reports CNN.