FDA 483 - Absolutely Natural - April 24, 2025

Absolutely Natural, a manufacturer in Melbourne, FL, received a Form 483 following an FDA inspection from April 22-24, 2025. The inspection revealed significant deficiencies in quality control, laboratory practices, and equipment management, particularly concerning water system validation, microbial testing, and cleaning verification for human OTC drug products and cosmetics. Several observations, including issues with test method validation and component identity testing, were repeat findings from a previous inspection in 2019, indicating persistent non-compliance.