FDA 483 - Rxhomeo Private Limited - May 15, 2023

Rxhomeo Private Limited, a human homeopathic drug manufacturer in Hyderabad, India, received a Form 483 with two observations during an FDA inspection. The firm was cited for inadequate laboratory controls, specifically regarding water sampling and testing, and for failing to establish or follow written procedures for production and process controls. These deficiencies indicate a lack of scientific justification and proper documentation for critical quality assurance processes.