FDA 483 - MEGHMANI LLP - February 03, 2026

An FDA inspection of MEGHMANI LLP, an API and OTC drug manufacturer in Dahej, Gujarat, India, revealed significant deficiencies across multiple areas of Good Manufacturing Practices. Observations included the use of unqualified equipment in a decommissioned area, poor facility maintenance with broken windows and widespread uncleanliness, and inadequate handling and storage of components risking contamination. Further issues involved improper identification of drug product samples and in-process materials, commingling of rejected and in-expiry products, and a quality control unit failing to follow written procedures and maintain proper documentation.