FDA 483 - Naturich Cosmetique Labs - May 02, 2025

Naturich Cosmetique Labs in Garland, TX, a contract manufacturer of OTC drugs, received a Form 483 with six observations during an inspection from 4/28/2025 to 5/2/2025. The inspection revealed significant deficiencies in process validation, investigation of out-of-specification results and microbial contamination in the water system, raw material testing, batch record documentation, annual product review procedures, and cleaning validation. Several observations were repeats from previous inspections, indicating persistent issues with quality control and manufacturing processes.