Cosmetic Solutions LLC – FDA 483, Jul 31, 2026

Cosmetic Solutions LLC, an OTC drug manufacturer in Boca Raton, FL, received a Form 483 with seven observations, many of which were repeat findings. The inspection revealed significant deficiencies in quality control, including incomplete OOS investigations and CAPA verifications, inadequate laboratory controls for reserve samples and stability studies, and a failure to complete annual product reviews. Additional issues involved poor document control, unsanitized equipment with visible stains, and inadequate facility design and material storage leading to potential mix-ups and contamination.