FDA 483 - Naturich Cosmetique Labs - March 06, 2020

An FDA inspection of Natrich Labs Inc., an OTC manufacturer in Garland, TX, revealed significant deficiencies in their quality system and production processes. Observations included a failure to investigate unexplained discrepancies in mixing times, inadequate batch production records lacking documentation for critical manufacturing steps, and a complete absence of product validation procedures. These issues indicate a lack of control over manufacturing processes and record-keeping.