FDA 483 - AET Laboratories Private Limited - February 07, 2025

AET Laboratories Private Limited, a drug manufacturer in Hyderabad, India, received a Form 483 with a repeat observation concerning inadequate equipment cleaning and maintenance. Inspectors noted frayed edges, rust, rough welds, and surface abrasions on manufacturing equipment used for commercial drug products, some of which were distributed to the United States. This indicates a persistent failure to prevent contamination and ensure drug product quality.