FDA wants proof Gilchrist & Soames soap-maker fixed contamination problems

The U.S. Food and Drug Administration is asking luxury hotel toiletry maker Gilchrist & Soames for proof that it’s cleaned up its products the way it promised.

Gilchrist & Soames voluntarily recalled some of its shampoos and shower gels last year after they were found to have microbial contamination.

This month, the FDA sent a letter to the company asking for proof of its corrective actions. The agency also recommended that the company “develop a remediation plan to correct and prevent future product contamination and subsequently provide for the safe distribution of your products.”

In 2015, in collaboration with the FDA, G&S conducted voluntary recalls of more than 2 million products that were contaminated with harmful bacteria. Two shower gels and two shampoos were found to contain what the Federal Food, Drug, and Cosmetic Act deems “poisonous or deleterious substances” — in this case, bacteria that are potentially harmful to human health.

One pathogen found in the bath products is known to be highly resistant to antibacterial agents and can cause life-threatening infections. Other pathogens found in these products can increase users’ risk of infection, which is most dangerous for people with compromised immune systems.

The products affected were the Gilchrist & Soames Spa Therapy conditioning shampoo, shower gel, Pelican Hill shower gel and Essential Elements shampoo.

“The inspection and recall were completed last year and the warning letter provides further documentation of the issues identified last year. There was no follow-up inspection and all of the issues raised are being addressed by our remedial actions. There are no current products under question or recall,” said Nehl Horton, senior vice president and chief communications and government relations officer of Sysco, which bought Gilchrist & Soames in 2015.

The FDA inspected Gilchrist & Soames’ Plainfield, Indiana, manufacturing facility in 2015 and found that the company failed to comply with standard sanitary procedures, which include routine evaluation of raw materials and proper maintenance of machinery.

“Your firm does not perform any microbial testing on any raw materials, nor have you validated your suppliers’ quality testing through independent verification,” the FDA wrote in its notice to Kathie DeVoe, president and CEO of G&S. The company was advised to develop a plan to prevent the recurrence of these violations.

In response to the FDA inspections, Gilchrist & Soames conducted a voluntary recall of these products. The company also temporarily closed parts of its Indiana facility for cleaning.

“Based on a thorough review of the facility and processes by an independent subject matter expert in microbiology, G&S has introduced new procedures, including increased testing of product, enhanced sanitation and new associate training,” Horton said in a statement.

“We take seriously the issues raised by the FDA and will continue to work closely with the agency to demonstrate that we have acted quickly and thoroughly to address its concerns.”

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