FDA Sends Warning Letter to Gilchrist & Soames

A warning letter has been sent to Gilchirst & Soames’ CEO Kathie De Voe following a U.S. Food and Drug Administration (FDA) inspection of the company’s cosmetic manufacturing facility in Plainfield, IN from Sept. 22 to Oct. 5, 2015.
 
The facility manufactures and distributes hotel amenity products, including shower gels, shampoos, lotions, and conditioners, to retail and charitable organizations.
 
In the letter, FDA says samples of “Gilchrist & Soames Spa Therapy Conditioning Shampoo” product during the inspection, and “(b)(4) Shower Gel,” “Pelican Hill Shower Gel,” and “Essential Elements Shampoo” products post-inspection had significant microbial contamination.
 
FDA analysis of the “Gilchrist & Soames Spa Therapy Conditioning Shampoo” and “(b)(4) Shower Gel” products determined that of the five subsamples analyzed for each product, all contained the pathogen Pseudomonas aeruginosa, which is opportunistically pathogenic to humans and highly resistant to antibacterial agents such as quaternary ammonium compounds, penicillin, and many broad-spectrum antibiotics. It is among the most virulent opportunistic pathogens and can cause severe and life-threatening infections (especially in immunocompromised patients, burn patients, patients suffering from respiratory disease, cancer, chemotherapy patients, etc.). P. aeruginosa can survive in topical and eye-area cosmetics and has been implicated in significant eye infections which may lead to corneal ulcers and blindness.
 
Analysis of “Gilchrist & Soames Spa Therapy Conditioning Shampoo,” “(b)(4) Shower Gel,” “Pelican Hill Shower Gel,” and “Essential Elements Shampoo” products determined that the subsamples of the products contained an excessive level of microorganisms as evidenced by high Aerobic Plate Counts (APC), which may render them injurious to users because the presence of such microorganisms in these finished products can increase the users' risk of infection. APC measures the level of microorganisms in a product and can indicate the quality of the product. FDA's guideline is that the APC should not be greater than 500 CFU/g for eye area cosmetics and 1,000 CFU/g for all other products.
 
FDA investigators also observed the insanitary practices that could cause products to be adulterated under section 601(c) of the Act. Specifically, FDA observed:
 
The microbiological safety of starting materials and/or raw ingredients is not routinely evaluated. Materials are not sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage. FDA says the firm does not perform any microbial testing on any incoming raw materials, nor have you validated your suppliers' quality testing through independent verification.
 
FDA also said that the equipment used to manufacture products is not maintained in a clean and orderly condition, or sanitized at appropriate times. FDA noted that the firm was also unable to document clean out procedures for (b)(4) gallon bulk raw material tanks and (b)(4) gallon tank(b)(4) water tank use for manufacturing and equipment cleaning.
 
Raw materials, in-process samples and finished products should be tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants. However, the firm's products continue to be contaminated with microorganisms. Specifically, P. aeruginosa was isolated by FDA from a sample of 1.5 oz bottles of “Thymes naia Body Wash” lot 1308, collected by an FDA investigator on December 17, 2014. The analytical results for this sample were sent to Gilchrist & Soames on March 6, 2015. Yet, P. aeruginosa was isolated from FDA samples of “Gilchrist & Soames Spa Therapy Conditioning Shampoo,” packaged in June, 2015, and ” (b)(4) Shower Gel,” “Pelican Hill Shower Gel,” and “Essential Elements Shampoo,” all packaged in September, 2015.
 
FDA said it acknowledged that the firm had recalled several products due to microbiological contamination. Specifically, (b)(4) Conditioning Shampoo batch 1320411346 lot 1308, London Shower Gel batch 1322707388 lot 1308, AM Resorts Dreams Conditioning Shampoo batches 1320410798 and 1320410603 lot 1307, Chamomile Mineral Bath batch 1320607414 lot 1308, and Neil George Body Wash batch 1314907424 lot 1307.

The full letter can be accessed here.
 
In September 2015, PE firm Swander Pace Capital sold Gilchrist & Soames to Guest Supply, a wholly owned subsidiary of Sysco Corporation.