FDA 483 - Natren, Inc. - November 02, 2023

An FDA inspection of Natren, Inc. in Westlake Village, CA, a manufacturer of homeopathic drug products, revealed significant deficiencies in quality control and manufacturing practices. Observations included failures in testing and releasing components before use, lack of a written stability assessment program for drug products, and an inadequately defined and independent quality control unit. These issues raise concerns about the quality, safety, and efficacy of the firm's homeopathic products.