Gilchrist & Soames Inc., which makes luxury toiletries for the hotel industry, is under warning from the Food and Drug Administration (FDA) to clean up operations at its local plant.
According to the FDA, Gilchrist & Soames conducted voluntary recalls of more than 2 million products that were potentially contaminated with harmful bacteria in 2015, the Indianapolis Business Journal reports.
In a warning letter sent to company president and CEO Kathie De Voe on March 16, the FDA asked Gilchrist & Soames for proof of corrective actions. The agency asked the manufacturer to “develop a remediation plan to correct and prevent future product contamination and subsequently provide for the safe distribution of your products.” Gilchrist & Soames has since recalled more of its shower gels and shampoos after microbial contamination was found, IBJ reports.
In an inspection of Gilchrist & Soames’s 250,000-square-foot plant in September and October 2015, the FDA found “poisonous or deleterious substances” in the two Gilchrist & Soames shampoos and two shower gels. The tainted products are Gilchrist & Soames Spa Therapy Conditioning Shampoo, Gilchrist & Soames Spa Therapy Shower Gel, Pelican Hill Shower Gel and Essential Elements Shampoo. A pathogen in the bath products is highly resistant to antibacterial agents and can cause severe and life-threatening infections. Other pathogens found in the products can increase risk of infection, especially for anyone with a compromised immune system, the FDA explains.
FDA inspectors found unsanitary practices at the manufacturing facility that could lead to contaminated products. The company temporarily closed parts of the plant for cleaning and said in a statement that it “has introduced new procedures, including increased testing of product, enhanced sanitation and new associate training.”
Gilchrist & Soames was founded in England in 1975 by brothers Tony and Michael Karger, IBJ reports. Potter & Moore bought the company in 1984. Indianapolis-based E&A Industries acquired the company and moved North American operations to Indianapolis in 1998. Gilchrist and Soames purchased Guest Supply, a subsidiary of the food-distribution company Sysco Corp., in late 2015. Guest Supply sells about $60 million in products annually and provides toiletry products for nearly 25,000 hotels, resorts and spas in more than 100 countries.
As is customary with FDA warning letters, the company has 15 business days from receipt of the letter to tell the FDA in writing the specific steps it has taken to correct the violations. Gilchrist & Soames must explain each step being taken to correct the violations and ensure that similar violations will not occur again. “If corrective action cannot be completed within 15 working days of receiving this letter, we expect that you will state the reason for the delay and the time frame within which the corrections will be completed,” the letter states.