FDA 483 - Absolutely Natural - June 14, 2019

Absolutely Natural, Inc. in Melbourne, FL, was inspected regarding its manufacturing of OTC drug products and cosmetics. The inspection revealed significant deficiencies in quality control, including inadequate water system management, non-validated testing methods, insufficient raw material and finished product testing, and a lack of written procedures. These issues indicate a severe lack of control over product quality and safety, potentially rendering products injurious to health.