FDA 483 - Murty Pharmaceuticals, Inc - March 28, 2025

An FDA inspection of Murty Pharmaceuticals, Inc. in Lexington, KY, identified two significant observations. The firm's laboratory controls were found deficient regarding sampling methods for microbial testing and the identification of microorganisms in their water system. Additionally, equipment logs lacked essential details such as time, product, and lot numbers for processed batches, hindering proper documentation.