FDA 483 - Sandoz Private Limited - July 02, 2024

An FDA inspection of Sandoz Private Limited in Navi Mumbai, India, from June 24 to July 2, 2024, identified a significant deficiency in the firm's procedures for preventing objectionable microorganisms in non-sterile drug products. The environmental monitoring program, particularly the microbiological laboratory's practices for capturing contaminants, was found to be inadequate, compromising the accuracy and reliability of results.