FDA 483 - Rxhomeo Private Limited - February 01, 2019

An FDA inspection of Rxhomeo Private Limited, a homeopathic drug manufacturer in Hyderabad, Telangana, India, revealed significant deficiencies across its quality system. The firm lacks numerous essential written procedures for production, process controls, equipment management, and quality control. Additionally, batch production records are incomplete, and there are failures in component release, labeling controls, product specifications, instrument calibration, and stability assessments.