FDA WARNING_LETTER - Gemdo Cosmetics, Inc. - December 23, 2014

The FDA inspected Gemdo Cosmetics Inc.'s contract cosmetic manufacturing facility from December 8-23, 2014, following a Class II Recall of Juice Beauty Illuminating Eye Shadow products due to *Bacillus cereus* contamination. The inspection found the eye shadow products adulterated under Section 601(a) of the Act because they contained *Bacillus cereus*, an ocular pathogen that can cause severe eye infections.

Furthermore, the facility's conditions caused Juice Beauty Illuminating Eye Shadow and other dry room products to be adulterated under Section 601(c) due to insanitary conditions. Environmental samples from the dry room tested positive for *Bacillus cereus*, indicating a lack of proper cleaning and sanitization, including ineffective spore disinfection.

The inspection also revealed insanitary practices: raw materials were not routinely evaluated for microbial safety, and incoming lots were not tested to confirm suitability. The firm lacked written quality control measures for raw materials, and some ingredients were past their recommended use dates.

The FDA cited Sections 601(a) and 601(c) of the Federal Food, Drug, and Cosmetic Act. Gemdo Cosmetics was advised to implement quality controls, reconditioning processes, and a remediation plan to prevent future contamination. The company was required to respond within fifteen working days, detailing corrective actions and timelines, with potential enforcement actions like seizure or injunction for non-compliance.