FDA 483 - Newton Laboratories, Inc. - March 26, 2026

Newton Laboratories, Inc., a homeopathic drug manufacturer in Conyers, GA, was cited for significant deficiencies during an FDA inspection. Observations included a failure to maintain an adequate stability testing program for its finished products, particularly after a container closure system change, and a lack of stability data for many batches. Additionally, the firm's complaint handling procedures were found to be deficient, failing to include proper investigation, root cause analysis, and corrective actions for numerous leaking bottle complaints. Finally, the firm failed to conduct container closure integrity studies to ensure product protection, a concern exacerbated by the high volume of leaking bottle complaints and absent stability data.