FDA 483 - Newton Laboratories, Inc. - March 30, 2018

Newton Laboratories Inc., a homeopathic drug manufacturer in Conyers, GA, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple areas, including process validation, OOS/OOT investigations, quality unit responsibilities, complaint handling, annual product reviews, batch records, cleaning validation, and distribution records. Many of these issues indicate a systemic lack of adherence to cGMP requirements.